BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT ACCEL VR ICD

    MDR report key: 6104856 · Received November 15, 2016

    Report

    Report Number
    2938836-2016-14269
    Event Type
    Injury
    Date Received
    November 15, 2016
    Date of Event
    October 10, 2016
    Report Date
    October 10, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF PREMATURE BATTERY DEPLETION AND INAPPROPRIATE SHOCKS WERE NOT CONFIRMED IN THE LABORATORY. BASED ON ALL AVAILABLE PARAMETER AND USAGE INFORMATION, DEVICE LONGEVITY WAS FOUND TO BE WITHIN EXPECTED LIMITS. REVIEW OF THE DEVICE IMAGE NOTED EXCESSIVE BUT NORMAL HIGH VOLTAGE CHARGING. THE DEVICE WAS TESTED ON THE BENCH AND MAXIMUM HIGH VOLTAGE CHARGING WAS ANOMALOUS DUE TO THE DEVICE REACHING EOS. THE DEVICE WAS NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED DUE TO SUSPECTED PREMATURE BATTERY DEPLETION. THE DEVICE WAS AT EOL UPON INTERROGATION. PATIENT WAS UNRELIABLE TO FOLLOW UP AND ARRIVED IN CLINIC WITH DEVICE AT LOW VOLTAGE. PATIENT HAD RECEIVED MULTIPLE INAPPROPRIATE SHOCKS FOR RAPID AF DUE TO MEDICATION NON-COMPLIANCE. PATIENT WAS IN STABLE POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753926 CURRENT ACCEL VR ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD1215-36Q 3365758

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention