BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3872984 · Received June 13, 2014

    Report

    Report Number
    2938836-2014-11801
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    April 14, 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
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC. MULTIPLE INAPPROPRIATE SHOCKS WERE NOTED. LOW R-WAVE AMPLITUDES, HIGH CAPTURE THRESHOLD, AND DECREASE IN PACING LEAD IMPEDANCE WERE ALSO NOTED. X-RAY REVEALED THAT THE LEAD HAD DISLODGED. THE PATIENT THEN UNDERWENT A VT ABLATION PROCEDURE DURING WHICH LEAD PERFORATION WAS FOUND. THE LEAD WAS SUCCESSFULLY REPOSITIONED, AND THE PATIENT WAS IN GOOD CONDITION FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349213 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7122Q/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention