BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT PLUS VR, DF4 CONNECTOR

    MDR report key: 3220395 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04411
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 22, 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 THE PATIENT RECEIVED INAPPROPRIATE VF THERAPIES. THE DEVICE REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321013 CURRENT PLUS VR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD1211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1