BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 1955194 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00390
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 26, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. ANALYSIS FOUND THAT THE NOISE AND INAPPROPRIATE SHOCKS OBSERVED IN THE FIELD WERE DUE TO A FRACTURED SENSING COIL, CLOSE TO THE CRIMP SLEEVE TO THE CONNECTOR RING. THE CRIMP SLEEVE WAS EXPOSED OUTSIDE THE CONNECTOR BORE, CAUSING INCREASED STRESS AND ACCELERATED FATIGUE TO THE SENSING COIL, OVER TIME RESULTING IN FRACTURE. THIS RESULTED IN AN INTERMITTENT OPEN CIRCUIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO NOISE ON THE LEAD. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7122/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention