BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 2864930 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17572
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    October 9, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE DOCTORS VIA AMBULANCE DUE TO THE RIGHT VENTRICULAR LEAD ALERTING. HIGH IMPEDANCE WAS NOTED AS WELL AS OVERSENSING, WHICH WAS INCORRECTLY CLASSIFIED AS NON-SUSTAINED TACHYCARDIA EPISODES. A LEAD REPLACEMENT WAS ATTEMPTED, HOWEVER THE STYLET WAS UNABLE TO BE ADVANCED INTO THE CHRONIC LEAD. CONSEQUENTLY, THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND REPLACED AND THE HIGH VOLTAGE PORTION REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| R