BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADENCE V-110 SERIES TIERED THERAPY DEFIBRILLATOR

    MDR report key: 117482 · Received September 5, 1997

    Report

    Report Number
    2938836-1997-00103
    Event Type
    Injury
    Date Received
    September 5, 1997
    Date of Event
    August 6, 1997
    Report Date
    August 6, 1997
    Manufacturer
    VENTRITEX, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H.3 EVAL SUMMARY: AS THE DEVICE WAS NOT RETURNED, AND EVAL WILL NOT BE PERFORMED.

    Description of Event or Problem · 1

    DURING A ROUTINE FOLLOW-UP, INTERROGATION OF THE DEVICE SHOWED A RESET AND CRYSTAL FAILURE MESSAGE. PRINTOUTS SHOWED AN ERRONEOUS SERIAL NUMBER AND DIAGNOSTIC DATA. AN EXPLANT WAS PERFORMED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADENCE V-110 SERIES TIERED THERAPY DEFIBRILLATOR Implant IMPLANTABLE CARDIAC DEFIBRILLATOR LWS VENTRITEX, INC. V-110C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other CPI A67, C10, L67, 4312, 4312 & 6836.