BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 2984396 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00478
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    October 22, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    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 A FRACTURE OF THE OUTER COIL WAS FOUND AT 5.8CM FROM THE CONNECTOR PIN. THIS FRACTURE IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF NOISE AND INAPPROPRIATE THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INAPPROPRIATE THERAPY DUE TO NOISE WAS OBSERVED ON THE RV AND RA CHANNELS. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89064 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 76 YR 1788TC/58, BAN78652