BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2972782 · Received February 21, 2013

    Report

    Report Number
    1644487-2013-00476
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT FLUID LEAKS WERE FOUND IN THE LEAD DURING PRODUCT ANALYSIS OF THE LEAD. THE LEAD WAS RETURNED DUE TO AN INFECTION REPORTED ON MEDWATCH #1644487-2013-00055. THE ABRADED OPENINGS FOUND ON THE OUTER AND INNER SILICONE TUBES AND THE PUNCTURE MARK FOUND ON THE OUTER SILICONE TUBING, MOST LIKELY PROVIDED THE LEAKAGE PATH FOR WHAT APPEARED TO BE REMNANTS OF DRIED BODY FLUIDS FOUND INSIDE THE OUTER AND INNER SILICONE TUBES OF THE LEAD. WHAT APPEARED TO BE WHITE DEPOSITS WERE OBSERVED IN VARIOUS LOCATIONS. EDS (ENERGY DISPERSION SPECTROSCOPY - PROVIDES CHEMICAL OR ELEMENT IDENTITY/COMPOSITION ANALYSIS) WAS PERFORMED AND IDENTIFIED THE DEPOSIT AS CONTAINING PHOSPHORUS, SODIUM, SULPHUR AND CALCIUM. EXCEPT FOR THE ABRADED OPENINGS, THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. WITH THE EXCEPTION OF THE ABRADED TUBING OPENINGS, NO OBVIOUS ANOMALIES WERE NOTED. THE SETSCREW MARKS FOUND ON THE CONNECTOR PINS PROVIDE EVIDENCE THAT, AT ONE POINT IN TIME, A GOOD MECHANICAL AND ELECTRICAL CONNECTION WAS PRESENT. CONTINUITY CHECKS OF THE RETURNED LEAD PORTION WERE PERFORMED, DURING THE VISUAL ANALYSIS, WITH NO DISCONTINUITIES IDENTIFIED. BASED ON THE FINDINGS IN THE PRODUCT ANALYSIS LAB, THERE IS EVIDENCE OF AN ABRADED INNER TUBING OPENING IN THE RETURNED PORTION OF THE DEVICE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76534 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS INC 300-20 16992C

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR