BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3872972 · Received June 13, 2014

    Report

    Report Number
    2938836-2014-11874
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 27, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL. A LEAD TIP STIFFNESS TEST WAS PERFORMED AND THE LEAD WAS FOUND TO BE WITHIN SPECIFICATION. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED TO THE HOSPITAL FOR A ROUTINE DEVICE CHECK. LOSS OF CAPTURE WAS OBSERVED. AN X-RAY WAS PERFORMED AND REVEALED PERFORATION OF THE HEART. WHEN REPOSITIONING WAS UNSUCCESSFUL THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350048 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7120Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention 1581/65 RH13330