BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    MDR report key: 3791082 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10476
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    March 30, 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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS ALERTED FOR NON-SUSTAINED LEAD NOISE. REVIEW OF STORED EGMS SHOWED THE PATIENT RECEIVED INAPPROPRIATE ATP THERAPY DUE TO FAR P-WAVE OVERSENSING. LEAD DISLODGEMENT WAS SUSPECTED. THE LEAD WAS EXPLANTED AND REPLACED WHEN REPOSITIONING WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269175 DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7121Q/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention