BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2241440 · Received August 18, 2011

    Report

    Report Number
    1644487-2011-01910
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    April 28, 2011
    Report Date
    July 19, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P9790003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    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 THAT THE VNS PATIENT HAD BEEN EXPERIENCING PAINFUL STIMULATION IN HER NECK AND HER VNS GENERATOR INDICATED 4 MONTHS LEFT ON HER VNS BATTERY. IT WAS BELIEVED THAT THE PAINFUL STIMULATION MAY HAVE BEEN RELATED TO THE BATTERY NEARING DEPLETION; HOWEVER, THE PAINFUL STIMULATION PERSISTED FOLLOWING VNS GENERATOR REPLACEMENT. THE EXPLANTED GENERATOR WAS RETURNED AND NO ANOMALIES WERE FOUND WITH THE PERFORMANCE OF THE GENERATOR. ADDITIONAL INFORMATION WAS LATER RECEIVED INDICATING THE PATIENT WAS BEING REFERRED FOR LEAD REPLACEMENT BECAUSE A LEAD FRACTURE WAS SUSPECTED. A MANUFACTURER REPRESENTATIVE AT THE LEAD REPLACEMENT SURGERY DISCOVERED THAT THE PATIENT HAD PREVIOUSLY FRACTURED HER CLAVICLE PRIOR TO THE GENERATOR REPLACEMENT AND NEEDED TO HAVE A PLATE PLACED ON HER LEFT CLAVICLE. THE PHYSICIAN BELIEVES THE PLACEMENT OF THE PLATE DAMAGED THE LEADS. X-RAYS TAKEN SHOW THAT THE SCREWS OF THE PLATE ARE IN THE LEAD PATH; HOWEVER, THESE X-RAYS HAVE NOT BEEN FORWARDED TO THE MANUFACTURER FOR REVIEW. LEAD IMPEDANCE WAS NORMAL FOLLOWING THE GENERATOR REPLACEMENT AS PER THE PHYSICIAN. THE VNS LEAD HAS BEEN REPLACED AND DIAGNOSTICS FOLLOWING REPLACEMENT ARE NORMAL. ATTEMPTS FOR THE RETURN OF THE EXPLANTED LEAD HAVE BEEN UNSUCCESSFUL TO DATE. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 NONE LYJ CYBERONICS, INC. 302-20 200241

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female