BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION LEAD

    MDR report key: 1223663 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03572
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    September 29, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP95022
    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

    NA

    Additional Manufacturer Narrative · 1

    AS RECEIVED, A PARTIAL LEAD WAS RETURNED. VISUAL INSPECTION FOUND INSULATION ABRASION AT 12.3 CM TO 14.5 CM FROM THE CONNECTOR PIN. THE ETFE INSULATION OF THE SVC CABLE WAS DAMAGED AT APPROXIMATELY 14 CM FROM THE CONNECTOR PIN. THE ABRASION FOUND IS CONSISTENT WITH THAT CAUSED BY FRICTION WITH THE ICD CAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT TWITCHING ON THE LEFT SIDE WHEN LYING DOWN. AT EXPLANT, INSULATION ANOMALY WAS OBSERVED. A TISSUE DISCOLORATION WAS OBSERVED IN THE ICD POCKET AREA DURING LEAD REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION LEAD DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention