BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 4870021 · Received June 25, 2015

    Report

    Report Number
    2938836-2015-27085
    Event Type
    Injury
    Date Received
    June 25, 2015
    Date of Event
    April 22, 2015
    Report Date
    May 7, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED TO THE CLINIC WHERE ALL THREE LEADS WERE OBSERVED TO BE DISLODGED DUE TO TWIDDLER'S SYNDROME. PATIENT WAS MILDLY SYMPTOMATIC. THE RV AND RA LEADS WERE EXPLANTED AND REPLACED. LV LEAD REMAINS IMPLANTED. PATIENT WAS FINE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412270 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 7122Q/58 4737781

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention (B)(4)| (B)(4)