BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 300

    MDR report key: 4954062 · Received July 30, 2015

    Report

    Report Number
    1644487-2015-05368
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 8, 2015
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2015 THAT HIGH IMPEDANCE WAS OBSERVED FOR A PATIENT DURING A ROUTINE CHECK. THE PHYSICIAN DECIDED NOT TO TURN THE DEVICE OFF. THE PATIENT WAS LAST SEEN 6 MONTHS PRIOR, AND NO TRAUMA TO THE AREA HAS BEEN REPORTED. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2015 AND IMPLANT CARD WAS RECEIVED INDICATING THAT PATIENT HAD A FULL REPLACEMENT ON (B)(6) 2015 DUE TO THE LEAD DISCONTINUITY. PRODUCT ATTEMPTS HAVE BEEN MADE BUT THE EXPLANTED DEVICES HAVE NOT BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    THE EXPLANTED GENERATOR AND LEAD HAVE BEEN RETURNED TO THE MANUFACTURER WHERE ANALYSIS IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED GENERATOR AND LEAD WAS COMPLETED. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. A BREAK WAS IDENTIFIED IN THE POSITIVE COIL OF THE RETURNED LEAD. SCANNING ELECTRON MICROSCOPY IMAGES OF THE POSITIVE COIL SHOW THAT PITTING OR ELECTRO-ETCHING CONDITIONS HAVE OCCURRED AT THE BREAK LOCATION. THE LEAD ASSEMBLY HAS DRIED REMNANTS OF WHAT APPEAR TO HAVE ONCE BEEN BODY FLUIDS INSIDE THE INNER AND THE OUTER SILICONE TUBING. NO OBVIOUS POINT OF ENTRANCE WAS NOTED OTHER THAN THE IDENTIFIED OPENINGS IN THE OUTER SILICONE TUBING AND THE CUT ENDS OF THE RETURNED LEAD PORTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498928 LEAD MODEL 300 LEAD LYJ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR