BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR AT

    MDR report key: 2812329 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02566
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME TO A DEVICE MARKETED IN THE U.S.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. A HIGH CURRENT DRAIN CONDITION WAS FOUND DURING DEVICE ANALYSIS. ELECTRICAL ANALYSIS REVEALED THE CAUSE OF THE HIGH CURRENT DRAIN WAS CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS. PRODUCT EVALUATION SUMMARY: PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. BATTERY VOLTAGE - BATTERY DEPLETION INDICATED/ERI: TIME OF RECOMMENDED REPLACEMENT TIME (RRT) IN SAVE TO DISK ON (B)(6) 2012 DEVICE RRT <(><<)>=2.62 VOLT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) DEVICE DID NOT MEET THE PERCEIVED LONGEVITY ESTIMATES. THE CRT-D DEVICE WAS REMOVED AND WAS REPLACED WITH A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO CRT-D DR AT IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. C174AWK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R