BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT PLUS VR

    MDR report key: 2242453 · Received September 10, 2011

    Report

    Report Number
    2017865-2011-06530
    Event Type
    Injury
    Date Received
    September 10, 2011
    Date of Event
    June 2, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE REPORTED EVENT WAS CONFIRMED IN THE LABORATORY. VISUAL INSPECTION FOUND THE HV CAPACITOR WAS BLOATED. AFTER REPLACING THE ORIGINAL HV CAPACITOR PAIR, THE CHARGE TIME WAS NORMAL. THE CAUSE OF THE EXTENDED CHARGE TIME ANOMALY WAS ISOLATED TO THE ORIGINAL HV CAPACITOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO EXTENDED CHARGE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD1211-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention