BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3052506 · Received April 11, 2013

    Report

    Report Number
    1644487-2013-00986
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED DEVICE MET SPECIFICATIONS PRIOR TO DISTRIBUTION. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ON (B)(4) 2013 IT WAS REPORTED THAT THE VNS PATIENT HAD HIGH IMPEDANCE DURING A CLINICAL VISIT THAT DAY. THE PATIENT WAS REFERRED FOR X-RAYS. THE MANUFACTURING RECORDS FOR THE LEAD WERE REVIEWED AND THE DEVICE MET ALL SPECIFICATIONS PRIOR TO DISTRIBUTION. A BLC WAS PERFORMED WHICH SHOWED 9.37 YEARS REMAINING UNTIL ERI=YES. THE PHYSICIAN LATER REPORTED THAT THE GENERATOR WAS DISABLED DUE TO THE HIGH IMPEDANCE AND X-RAYS WERE TAKEN BUT THE PATIENT WAS SCHEDULED FOR SURGERY BEFORE THE X-RAYS COULD BE SENT BACK TO THE PHYSICIAN. IT WAS UNKNOWN IF ANY PATIENT MANIPULATION OR TRAUMA OCCUR THAT IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE. THE PATIENT UNDERWENT A FULL REVISION SURGERY ON (B)(6) 2013. IT WAS REPORTED THAT THE HOSPITAL DOES NOT RETURN EXPLANTED PRODUCTS TO THE MANUFACTURER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 12, 2013 WHEN IT WAS REPORTED THAT THE LEAD IMPEDANCE AFTER SURGERY WAS WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156880 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 200631

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR