BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 1831188 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03218
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 28, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    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.

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND INSULATION ABRASIONS FROM THE INSIDE OUT AT SEVERAL PLACES. THE APPEARANCE AND POSITIONING OF THE DAMAGE AT 15 AND 29 CM FROM THE CONNECTOR PIN INDICATES THAT THE LEAD BODY HAD ABRADED WITH ANOTHER IMPLANTED DEVICE. BECAUSE OF THE ABRASION, THE RV CABLE HAD FRACTURED OVER TIME AT 29 CM FROM THE CONNECTOR PIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ICD REPLACEMENT, IT WAS FOUND THAT THE LEAD HAD TWO AREAS OF INSULATION DAMAGES. HENCE, THE LEAD WAS EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC SLEEVE PROCEDURE, THE RELOAD DIDN'T FIRE, AND 4 DIFFERENT RELOADS DIDN'T FIRE. THE DEVICE WAS REPORTED BECAUSE ALL OF THE RELOADS WERE FIRED IN A DEFECT WAY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1572/65

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention