BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1223527 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03616
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    September 24, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP95022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT TRIPPED AND FELL AND LANDED ON THE SHOULDER WHERE THE DEVICE IS LOCATED. SINCE THAT TIME, THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY FOR NOISE THAT WAS INTERPRETED AS A TACHYCARDIA. THE LEAD WAS CAPPED, AND THE DEFIB PORTION OF LEAD REMAINS ACTIVE. LEAD DAMAGE WAS OBSERVED AT EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention