BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 2984288 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00475
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    December 26, 2012
    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 Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FRACTURE OF THE CONDUCTORS WAS FOUND AT 19.0-19.6CM FROM THE CONNECTOR PIN. THIS IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF HIGH HV LEAD IMPEDANCE. INTERNAL INSULATION ABRASION WAS NOTED AT 19.9-20.7CM FROM THE CONNECTOR PIN. THE OPTIM INSULATION WAS INTACT.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC AFTER RECEIVING A PATIENT NOTIFIER ALERT. UPON INTERROGATION, IT WAS NOTED THAT THE HV LEAD IMPEDANCE HAD INCREASED AND WAS OUT OF RANGE. IT WAS ALSO NOTED THAT THE PATIENT HAD BEEN IN A CAR ACCIDENT AT APPROXIMATELY THE SAME TIME AS THE ALERT. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86421 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7122/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR