BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 3903765 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12777
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 8, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS CAPPED DUE TO HIGH IMPEDANCE AND HIGH PACING THRESHOLD. LEAD FRACTURE WAS SUSPECTED. PATIENT WAS WELL AFTER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380934 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7120/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention