BEUDAMED
    FDA Adverse Event Death Summary report: N

    STRIDE

    MDR report key: 814624 · Received February 6, 2007

    Report

    Report Number
    2124215-2007-99537
    Event Type
    Death
    Date Received
    February 6, 2007
    Date of Event
    January 8, 2007
    Report Date
    January 30, 2007
    Manufacturer
    ITM
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONCLUSION: THE DEVICE HAS BEEN REC'D AND IS CURRENTLY BEING ANALYZED BY THE RELIABILITY ASSURANCE LABORATORY. UPON COMPLETION OF ANALYSIS, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    EVENT DESCRIPTION BOSTON SCIENTIFIC CRM REC'D INFO THAT THE PT WITH THIS PACEMAKER EXPIRED (DATE OF DEATH IN 2007), DUE TO UNK CAUSES. THERE WAS NO CLINICAL ALLEGATION AGAINST DEVICE OR LEAD PERFORMANCE, HOWEVER, THE PT'S FAMILY WAS CONCERNED THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE DEATH. INTERROGATION OF THE DEVICE IN THE MORGUE WAS SUCCESSFUL, AND GAVE A CELL VOLTAGE OF 2.5 K OHMS IN COLDER TEMPS. THIS CELL VOLTAGE IS NEAR ELECTIVE REPLACEMENT TIME (ERT) IN THIS MODEL DEVICE. THE DEVICE WAS IN SVC FOR 8.8 YRS, WHICH EXCEEDS THE MINIMUM LONGEVITY EXPECTED FOR 6.5 YRS AT NOMINALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRIDE IMPLANTABLE PULSE GENERATOR DXY ITM 294-05 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death 5024M/LAV065586V| 5024M/LAV039281V