BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANALYST DR, DF-4 CONNECTOR

    MDR report key: 4220973 · Received November 3, 2014

    Report

    Report Number
    2938836-2014-17468
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    August 21, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION INCLUDED. THE REPORTED FIELD EVENT OF PREMATURE BATTERY DEPLETION WAS CONFIRMED IN THE LABORATORY. A LONGEVITY CALCULATION WAS PERFORMED AND FOUND TO BE WITHIN EXPECTED LIMITS. THE DEVICE WAS TESTED ON THE BENCH AS WELL AS USING AUTOMATED TEST EQUIPMENT AND NO ANOMALIES WERE FOUND. THE ORIGINAL BATTERY WAS RETURNED TO THE VENDOR FOR FURTHER ANALYSIS. AN INTERNAL ANOMALY WITHIN THE BATTERY WAS FOUND TO BE THE CAUSE OF THE PREMATURE BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW UP, PREMATURE BATTERY DEPLETION WAS OBSERVED. THE DEVICE WAS EXPLANTED AND REPLACED. PATIENT CONDITION IS STABLE AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702524 ANALYST DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2217-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention