BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1761252 · Received July 15, 2010

    Report

    Report Number
    1644487-2010-01639
    Event Type
    Malfunction
    Date Received
    July 15, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 15, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 TO THE MFR THAT THE VNS PT'S DEVICE SHOWED HIGH LEAD IMPEDANCE DURING DIAGNOSTIC TESTING AT AN OFFICE VISIT. THE PT'S GENERATOR IS NOT AT END OF SERVICE. IT IS UNK IF THERE WAS ANY PT MANIPULATION OR TRAUMA AT THE DEVICE SITE THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IT IS UNK WHEN THE DIAGNOSTIC TESTS RESULTS ON THE PT'S VNS DEVICE WERE WITHIN NORMAL LIMITS. X-RAYS VIEWS WERE TAKEN TO ASSESS THE INTEGRITY OF THE SYSTEM. REVIEW OF THE X-RAY VIEWS OF THE DEVICE BY THE PT'S PHYSICIAN DID NOT REVEAL ANY ANOMALIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED HIGH LEAD IMPEDANCE EVENT. THE PT WAS REFERRED TO A SURGEON AND REVISION SURGERY IS LIKELY. GOOD FAITH ATTEMPTS TO OBTAIN X-RAY VIEWS FOR ASSESSMENT AND ADD'L INFO REGARDING THE REPORTED EVENT HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-30 1285

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female