BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 3216045 · Received July 10, 2013

    Report

    Report Number
    2938836-2013-03576
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    April 18, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INCREASED CAPTURE THRESHOLD AND HIGH PACING LEAD IMPEDANCE WERE OBSERVED. PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO OVERSENSING. LEAD FRACTURE OR INSULATION BREAK SUSPECTED. THE LEAD WAS REPLA CED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319204 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1571/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention