BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT ACCEL VR, DF4 CONNECTOR

    MDR report key: 3220315 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04413
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 14, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 POST IMPLANT, A LOW SENSING THRESHOLD WAS OBSERVED. THE MAX SENSITIVITY WAS REPROGRAMMED AND A DFT WAS PERFORMED. THE DEVICE SUCCESSFULLY TERMINATED THE VT/VF. AN INAPPROPRIATE VENTRICULAR PACE WAS SEEN SHORTLY AFTER THE DFT TESTING. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321329 CURRENT ACCEL VR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD1215-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1