BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 3153613 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06133
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    April 2, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCT: D164VWC IMPLANTABLE PACEMAKER/CARDIO/DEFIB - (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAD FRACTURE WAS SUSPECTED. ELEVATED IMPEDANCE, INCREASED NSVT (NON-SUSTAINED VENTRICULAR TACHYCARDIA), HIGH SHORT INTERVAL COUNTS (SIC), LEAD FAILURE ON EGM (ELECTROGRAM) AND NOISE BY SOME MOTION OF UPPER EXTREMITY WAS CONFIRMED. THE VENTRICULAR FIBRILLATION (VF) DETECTION WAS TURNED OFF AND THE LEAD REMAINS IN USE. IT IS NOTED THAT THE PATIENT HAS BEEN SCHEDULED FOR 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
    258647 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| R