BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 3903758 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12788
    Event Type
    Injury
    Date Received
    June 30, 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
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 49.0CM WAS RETURNED FOR ANALYSIS. INNER COIL DAMAGE WAS NOTED AT 41.0CM FROM THE CONNECTOR PIN CONSISTENT WITH CLAVICLE CRUSH DAMAGE. THE INNER COIL WAS FRACTURED. THIS IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF NOISE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380501 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7122/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention