BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPL LEAD, TRANSVENOUS

    MDR report key: 3210578 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03522
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    March 29, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RV LEAD NOISE WAS OBSERVED VIA REMOTE CARE. FLUORO IMAGES SUGGESTED THAT THE RV LEAD WAS NOT PROPERLY CONNECTED TO THE HEADER. THE CONNECTION WAS REVISED AND NOISE WAS STILL PRESENT. FURTHER INSPECTION INDICATED THAT THE PACE/SENSE PORTION OF THE LEAD HAD AN INSULATION BREAK ON THE PACE/SENSE PORTION. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310730 SPL LEAD, TRANSVENOUS DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION SP02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention