If this is your first visit, be sure to check out the FAQ in HCMA Announcements. You may have to register before you can post: click the register link above to proceed. To start viewing messages, select the forum that you want to visit from the selection below. Your Participation in this message board is strictly voluntary. Information and comments on the message board do not necessarily reflect the feelings, opinions, or positions of the Hypertrophic Cardiomyopathy Association. At no time should participants to this board substitute information within for individual medical advice. The Hypertrophic Cardiomyopathy Association shall not be liable for any information provided herein. All participants in this board should conduct themselves in a professional and respectful manner. Failure to do so will result in suspension or termination. The moderators of the message board working with the HCMA will be responsible for notifying participants if they have violated the rules of conduct for the board. Moderators or HCMA staff may edit any post to ensure it conforms with the rules of the board or may delete it. This community is welcoming to all those with HCM we ask that you remember each user comes to the board with information and a point of view that may differ from that which you hold, respect is critical, please post respectfully. Thank you

Announcement

Collapse
No announcement yet.

now St Jude has problems...

Collapse

About the Author

Collapse

Lisa Salberg Find out more about Lisa Salberg
X
 
  • Filter
  • Time
  • Show
Clear All
new posts

  • now St Jude has problems...

    Device Makers Recall and Retool

    By Althea Chang
    TheStreet.com Staff Reporter
    6/21/2005 4:53 PM EDT


    In the last two days, St. Jude Medical (STJ:NYSE - commentary - research) said it would need to fix a software defect in some of its defibrillators, and word came that Medtronic (MDT:NYSE - commentary - research) received a warning letter from the Food and Drug Administration for failing to correct a problem at a facility that makes its Lifepak 12 device.

    On Friday, Guidant (GDT:NYSE - commentary - research) said 50,000 of its implantable cardiac defibrillators in service could be subject to defects that have led to 45 malfunctions. The company warned doctors about possible problems with some of the devices and said two patients with defibrillators covered by the notification have died.




    If bad news does in fact come in threes, the medical-device makers should be in the clear for the foreseeable future.

    As for Guidant, SG Cowen analyst David Clayton says he remains positive on the company. And whereas Alexander Arrow of Lazard Capital Markets estimates recalls could cost Guidant as much as $225 million, St. Jude says it doesn't expect its advisory of possible software issues to have any material financial effect.

    Guidant shares traded down 88 cents to $69.42.

    St. Jude, based in St. Paul, Minn., said Monday that 39,000 of its implantable cardiac defibrillators need a noninvasive software upgrade to correct two "anomalies" found during a routine product evaluation. After examining a single returned ICD, the company said the device may deliver fewer than the intended six shocks when a patient's heart begins to beat at a dangerous pace.

    The company said there were no reported adverse events. St. Jude worked with the FDA and consulted a physician advisory panel, and the upgrade was approved by the government on June 17. Cowen's Clayton said the software defects are a noncore issue and the upgrade will be easily implemented.
    Also, "electrical noise" in some devices may cause an increased pacing rate. The software upgrade notice applies to the Epic and Atlas defibrillators. St. Jude shares were off 31 cents to $40.66.

    News of the issues affecting the companies closely follows a recent expansion of Medicare coverage of the implanted devices. The Centers for Medicare and Medicaid Services expects heart devices will be implanted in at least 25,000 additional patients in the first year of coverage, potentially saving up to 2,500 lives.


    Coronary heart disease is the most common cause of death in the U.S., according to the Centers. Sudden death, frequently from heart arrhythmias, is believed to account for about 50% of all coronary heart disease deaths. An implanted ICD monitors the heart's rhythm and delivers an electrical shock when a life-threatening arrhythmia is detected.

    Medicare's expanded coverage of the devices will increase the number of beneficiaries eligible for an ICD by one-third, to nearly 500,000.

    Meanwhile, the FDA said Medtronic failed to properly correct problems with its Lifepak 12 automated external defibrillators' therapy cables. Earlier this month, the FDA told Medtronic that its Lifepak 12 manufacturing facility doesn't conform to good manufacturing practice requirements.

    The agency also said that although defective cables in the devices were replaced and inspected, there have been continued complaints of broken pins in the therapy cables.

    " [The company] should take prompt action to correct these deviations," the FDA said in its letter. "Failure to promptly correct these deviations may result in regulatory action being initiated by the FDA without further notice."

    Medtronic shares were down 44 cents to $52.40.
    Knowledge is power ... Stay informed!
    YOU can make a difference - all you have to do is try!

    Dx age 12 current age 46 and counting!
    lost: 5 family members to HCM (SCD, Stroke, CHF)
    Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
    Therapy - ICD (implanted 97, 01, 04 and 11, medication
    Currently not obstructed
    Complications - unnecessary pacemaker and stroke (unrelated to each other)

  • #2
    St. Jude tells doctors of software problem in some defibrillators
    Janet Moore, Star Tribune
    June 21, 2005 JUDE0621



    St. Jude Medical Inc. has notified doctors and federal regulators of a software problem in some models of its implantable defibrillators that could cause the heart-shocking device to malfunction.

    About 39,000 patients are affected by the news, although the company said no deaths or injuries have occurred as a result.

    The Little Canada-based medical technology company said some models of its Atlas and Epic implantable defibrillator, or ICD, need a brief, noninvasive upgrade that can be done during an office checkup.

    The news comes as rival Guidant Corp., whose cardiac rhythm management division is based in Arden Hills, deals with the fallout from a recall of 50,000 of its ICDs last week. And, earlier this year, Fridley-based Medtronic recalled 87,000 ICDs that had a battery depletion problem.

    ICDs are implanted devices the size of a stopwatch that are placed in the upper chest and shock or pace an errantly beating heart back into rhythm.

    St. Jude said it discovered the two "anomalies" during a routine product evaluation. They include:

    • In ICDs past their mid-life, a series of shocks might be skipped as the device delivers its routine of multiple shocks to revitalize the patient's heart. The first shock would be delivered, but the device might deliver fewer than the maximum of six shocks per episode. The devices on average last four to seven years before replacement.

    • A second problem could cause a temporary increase in the device's pacing rate. (In addition to its shocking therapy, some patients need an ICD that can pace their heart, as well.)

    The company said the software upgrade was approved by the Food and Drug Administration on Friday.

    St. Jude is providing doctors with a software tool to correct the programmer, a tabletop computer that permits noninvasive communication with the implanted device.

    A wand is placed on the patient's chest and the computer will determine whether the ICD is among the affected lot. If so, new software will be downloaded to the device in a procedure the company said takes 45 seconds.

    St. Jude said company representatives will install the corrective software.

    The affected models include: Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF (V-236/V-239/V-196/V-239T/V-239T/V-196T/V-350), Atlas DR (V-242), and Atlas Plus DR/VR/HF (V-243/V-193/V-193C/V-340/V-341/V-343).
    Knowledge is power ... Stay informed!
    YOU can make a difference - all you have to do is try!

    Dx age 12 current age 46 and counting!
    lost: 5 family members to HCM (SCD, Stroke, CHF)
    Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
    Therapy - ICD (implanted 97, 01, 04 and 11, medication
    Currently not obstructed
    Complications - unnecessary pacemaker and stroke (unrelated to each other)

    Comment


    • #3
      Oh that's nice

      My son has the ST. Judes, I will be asking him his model and serial number

      Shirley
      Diagnosed 2003
      Myectomy 2-23-2004
      Husband: Ken
      Son: John diagnosed 2004
      Daughter: Janet (free of HCM)

      Grandchildren: Drew 15,Aaron 13,Karen 9,Connor 9

      Comment


      • #4
        This is ONLY a programming issue, and that means it is easy to correct AKA no replacement of device.

        Lisa
        Knowledge is power ... Stay informed!
        YOU can make a difference - all you have to do is try!

        Dx age 12 current age 46 and counting!
        lost: 5 family members to HCM (SCD, Stroke, CHF)
        Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
        Therapy - ICD (implanted 97, 01, 04 and 11, medication
        Currently not obstructed
        Complications - unnecessary pacemaker and stroke (unrelated to each other)

        Comment


        • #5
          Lisa

          I know it is a simple fix, it has just been one thing or another lately, i'm just glad mine doesn't have to be replaced right now, but i still have it in the back of my mind that they kept it from me for 3 years and what if they are covering again, but oh well what will be be will be everyone have a great day and weekend

          Shirley
          Diagnosed 2003
          Myectomy 2-23-2004
          Husband: Ken
          Son: John diagnosed 2004
          Daughter: Janet (free of HCM)

          Grandchildren: Drew 15,Aaron 13,Karen 9,Connor 9

          Comment

          Working...
          X