BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 2945830 · Received February 6, 2013

    Report

    Report Number
    2649622-2013-00076
    Event Type
    Death
    Date Received
    February 6, 2013
    Date of Event
    December 1, 2009
    Report Date
    January 11, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #THE DEVICE(S) ASSOCIATED WITH THIS ADVERSE OUTCOME WAS/WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. EVALUATION SUMMARY: LFJ107457V THE PROXIMAL SECTION OF THE LEAD WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. IT WAS NOTED THAT EXPLANT DAMAGE HAD OCCURRED INCLUDING INSULATION DAMAGE AND AN OVERSTRESS PROXIMAL CONDUCTOR FRACTURE. (B)(4).

    Description of Event or Problem · 1

    THE SYSTEM WAS RETURNED WITH NO INFORMATION. A DATABASE SEARCH BY SERIAL NUMBER SHOWED THE PATIENT EXPIRED LESS THAN 1 YEAR AFTER IMPLANT. THE DEATH OCCURRED GREAT THAN 2 YEARS AGO. NO COMPLAINTS, ALLEGATIONS, OR, PREVIOUS CONTACTS, REGARDING THE SYSTEM OR ANY INDIVIDUAL COMPONENTS HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51263 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Death 5076 PACING LEADS X2, 4193 PACING LEAD