BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT ACCEL VR, DF-4 CONNECTOR

    MDR report key: 1954788 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00486
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    October 15, 2010
    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. RELIABILITY LABORATORY TECHNICIAN. (B)(4) NO COMPLAINT WAS RECEIVED WITH RETURN OF THE DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. ANALYSIS FOUND THE BATTERY DEPLETED. THE DEVICE WAS ANALYZED WITH A NEW BATTERY AND FOUND TO BE NORMAL. THE ORIGINAL BATTERY WAS SENT OUT TO THE VENDOR FOR FURTHER EVALUATION AND NO ANOMALY WAS DETECTED. THE CAUSE FOR THE PREMATURE BATTERY DEPLETION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT ACCEL VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2215-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1