BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2951400 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00087
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 2, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: WE RECEIVED PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATE. NO ANOMALIES WERE FOUND. CONCOMITANT PRODUCT: 6947 IMPLANTABLE TACHY LEAD (B)(6) 2010; 5076 IMPLANTABLE PACING LEAD (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) DEVICE REACHED EARLY BATTERY DEPLETION. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD THRESHOLD WAS VERY HIGH. THEREFORE THE CRT-D DEVICE WAS REMOVED AND REPLACED WITH A NEW DEVICE AND THE LV LEAD WAS CAPPED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57666 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 419488

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB