BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT VR RF

    MDR report key: 3943868 · Received July 18, 2014

    Report

    Report Number
    2938836-2014-13448
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 2, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED IN CLINIC FOR FOLLOW. POST-SENSED T-WAVE OVERSENSING WAS OBSERVED ON A STORED EGM. THE PATIENT RECEIVED INAPPROPRIATE HV THERAPY. THE DEVICE WAS REPROGRAMMED DURING DEVICE CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421765 CURRENT VR RF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD 1207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention