BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR LEAD MODEL 302

    MDR report key: 773945 · Received August 18, 2006

    Report

    Report Number
    1644487-2006-00298
    Event Type
    Malfunction
    Date Received
    August 18, 2006
    Date of Event
    January 1, 2006
    Report Date
    July 21, 2006
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW 0F X-RAYS BY THE MFR DID NOT REVEAL ANY OBVIOUS DISCONTINUITIES IN THE VNS THERAPY SYSTEMS. THE VNS THERAPY SYSTEM IS INDICATED FOR USE AS AN ADJUNCTIVE IN REDUCING THE FREQUENCY OF SEIZURES IN ADULTS AND ADOLESCENTS OVER 12 YEARS OF AGE WITH PARTIAL ONSET SEIZURES THAT ARE REFRACTORY TO ANTIEPILEPTIC MEDICATIONS. IN THE UNITED STATES, THE VNS THERAPY SYSTEM IS APPROVED FOR USE IN ADULTS AND ADOLESCENTS OVER 12 YEARS OF AGE WITH PARTIAL ONSET SEIZURES THAT ARE REFRACTORY TO ANTIEPILEPTIC MEDICATIONS. DEVICE FAILURE SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT DEVICE DIAGNOSTIC TESTING ON A SYSTEM DIAGNOSTIC TEST AT AN OFFICE VISIT, RESULTED IN HIGH LEAD IMPEDANCE READING, INDICATING POSSIBLE LEAD FRACTURE. THE PT UNDERWENT REVISION SURGERY, DURING WHICH THE LEAD AND PULSE GENERATOR WERE EPXLANTED AND REPLACED. THERE WERE NO OBVIOUS LEAD BREAKS OBSERVED DURING SURGERY. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR LEAD MODEL 302 LYJ LYJ CYBERONICS, INC. 302-20 9273

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR IMPLANTED DATE:| EXPLANT DATE:| PULSE GEN MODEL 102