BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSIGNIA

    MDR report key: 1677985 · Received May 6, 2010

    Report

    Report Number
    2124215-2010-09339
    Event Type
    Death
    Date Received
    May 6, 2010
    Date of Event
    January 18, 2010
    Report Date
    June 21, 2024
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    DXY
    PMA / PMN Number
    N970003/S024
    Removal / Correction Number
    Z-0187-06 THRU Z-0190-06
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS PUT THROUGH AND PASSED A SERIES OF AUTOMATED DIAGNOSTIC TESTING THAT VERIFIES THE PERFORMANCE OF PACING, SENSING, AND RECORDING FUNCTIONS OF THE DEVICE COMMENSURATE WITH BATTERY VOLTAGE. THE DEVICE WAS FORWARDED FOR DETAILED TESTING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THE PT'S WIFE ALLEGED THE PT'S DEATH OCCURRED PARTIALLY DUE TO THIS PACEMAKER DEPLETING MORE QUICKLY THAN THEY EXPECTED AND WITHOUT WARNING. THE DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED WITH A NEW DEVICE ON (B) (6) 2010. THE DATE OF DEATH WAS (B) (6) 2010. THE OFFICIAL CAUSE OF DEATH WAS NOTED AS SEPSIS AND CARDIOPULMONARY ARREST. ALTHOUGH THE DEATH OCCURRED NINE DAYS AFTER THIS DEVICE WAS EXPLANTED, BASED ON CURRENT AVAILABLE INFO, WE ARE UNABLE TO REFUTE THAT THE DEVICE MAY HAVE NECESSITATED A REPLACEMENT PROCEDURE, WHICH IN TURN MAY HAVE CAUSED OR CONTRIBUTED TO THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR DXY GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Life Threatening| R| D 1290.| 4456.| 4469.| 1290| 4469| 4456