BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY CRT-D, DF4 CONNECTOR

    MDR report key: 2984405 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00563
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 29, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. (B)(6). MFR NAME: ST. JUDE MEDICAL CRMD RELIABILITY LABORATORY; NO COMPLAINT RECEIVED WITH RETURN OF DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. A PREMATURE BATTERY DEPLETION WAS OBSERVED. THE LOW BATTERY VOLTAGE WAS DETECTED PRIOR TO IMPLANT. THE DEVICE WAS TESTED USING OUR ATE SYSTEM AND NO ANOMALIES WERE FOUND. THE BATTERY WAS SENT TO THE MANUFACTURER FOR FURTHER ANALYSIS. THE CAUSE OF THE PREMATURE BATTERY DEPLETION WAS FOUND TO BE AN ANOMALOUS RF MODULE. IT IS BELIEVED THAT THE RF MODULE FAILURE CAUSED AN EXCESSIVE CURRENT DRAIN, WHICH DEPLETED THE BATTERY.

    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
    89067 UNIFY CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1