BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1070425 · Received July 3, 2008

    Report

    Report Number
    1644487-2008-01539
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 4, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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

    REPORTER INDICATED THAT SYSTEM DIAGNOSTIC TESTING RESULTED IN HIGH LEAD IMPEDANCE AT A VNS PT'S ROUTINE OFFICE VISIT. THE PHYSICIAN ALSO REPORTED THAT THE PT HAD HAD AN UPPER ENDOSCOPY PROCEDURE WHICH HE BELIEVED MAY HAVE CONTRIBUTED TO THE HIGH LEAD IMPEDANCE. DIAGNOSTIC TESTING WAS REPORTED TO BE NORMAL PRIOR TO THE ENDOSCOPY PROCEDURE. AFTER THE ENDOSCOPY PROCEDURE, THE PT REPORTED NO LONGER FEELING STIMULATION OF THE VNS DEVICE. NO OTHER PT MANIPULATION OR TRAUMA WAS REPORTED. THE SURGEON VIEWED THE PT'S X-RAYS AND REPORTED NO ANOMALIES. HOWEVER, X-RAYS HAVE NOT BEEN MADE AVAILABLE FOR THE MFR TO REVIEW. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE. REVISION SURGERY IS LIKELY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1