BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3162921 · Received June 11, 2013

    Report

    Report Number
    1644487-2013-01743
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THERE WERE NO UNRESOLVED NON CONFORMANCES FOUND WITH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD A GENERATOR AND LEAD REPLACEMENT. THE EXPLANTED PRODUCTS WERE DISCARDED DURING SURGERY. DIAGNOSTICS PRIOR TO SURGERY WERE OUTPUT STATUS ¿ LIMIT, IMPEDANCE ¿ HIGH, DCDC ¿ 7. PRIOR TO REPLACING THE LEAD SURGEON CHECKED THE PIN INSERTION AND REMOVED AND RE-INSERTED THE PIN BUT THE IMPEDANCE WAS STILL HIGH.

    Description of Event or Problem · 1

    FOLLOW UP FOUND THAT THERE WAS NO REPORTED TRAUMA OR MANIPULATION ACCORDING TO THE PHYSICIAN, REPORTED TO HIM BY THE PATIENT AND FAMILY. THERE WERE NO VNS DOSING OR MEDICATION CHANGES THAT SEEMED RELATED TO STIMULATION ISSUES. ALSO, X-RAYS WILL NOT BE SENT TO THE MANUFACTURER FOR REVIEW.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD HIGH IMPEDANCE AT A RECENT APPOINTMENT. THE TYPE OF DIAGNOSTICS WAS NOT LISTED BUT THE RESULTS WERE: OUTPUT CURRENT ¿ LIMIT, IMPEDANCE ¿ HIGH, DCDC ¿ 7. THE GENERATOR WAS LEFT ON AND THE PATIENT WAS SENT TO X-RAYS. THE PATIENT STILL GETS VOICE ALTERATIONS WITH STIMULATION BUT SAYS SOMETIMES SHE DOES NOT FEEL MAGNET STIMULATION. THE PATIENT WAS REFERRED FOR A LEAD REPLACEMENT. SURGERY IS LIKELY BUT HAS NOT OCCURRED TO DATE. REVIEW OF MANUFACTURING RECORDS CONFIRMED THERE WERE NO UNRESOLVED NON CONFORMANCES FOUND WITH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION. GOOD FAITH ATTEMPT FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262091 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 009493

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR