BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    MDR report key: 3781857 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-09955
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    February 18, 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND. A LEAD TIP STIFFNESS TEST WAS PERFORMED AND THE LEAD WAS FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH CAPTURE THRESHOLD AND A LOW SENSING WERE NOTED. PERFORATION WAS REPORTED. WHEN REPOSITIONING WAS UNSUCCESSFUL THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS STABLE DURING AND AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259111 DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7122Q/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention