BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3211721 · Received July 8, 2013

    Report

    Report Number
    1644487-2013-02048
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME; CORRECTED DATA: ADDITIONAL INFORMATION INDICATES THAT THE SUSPECT DEVICE IS THE GENERATOR. TYPE OF DEVICE, NAME; CORRECTED DATA: ADDITIONAL INFORMATION INDICATES THAT THE SUSPECT DEVICE IS THE GENERATOR. MODEL #, SERIAL #, LOT#, EXPIRATION DATE; CORRECTED DATA: ADDITIONAL INFORMATION INDICATES THAT THE SUSPECT DEVICE IS THE GENERATOR. OPERATOR OF DEVICE; CORRECTED DATA: ADDITIONAL INFORMATION INDICATES THAT THE OPERATOR OF THE DEVICE WAS THE HEALTH PROFESSIONAL. DATE OF IMPLANT; CORRECTED DATA: ADDITIONAL INFORMATION INDICATES THAT THE SUSPECT DEVICE IS THE GENERATOR. DATE OF EXPLANT; CORRECTED DATA: ADDITIONAL INFORMATION INDICATES THAT THE SUSPECT DEVICE WAS NOT EXPLANTED. DEVICE MANUFACTURE DATE; CORRECTED DATA: ADDITIONAL INFORMATION INDICATES THAT THE SUSPECT DEVICE IS THE GENERATOR.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THERE WERE NO UNRESOLVED NON CONFORMANCES FOUND WITH THE LEAD 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

    AN IMPLANT CARD WAS RECEIVED INDICATING THE PATIENT'S VNS DEVICE WAS REPLACED ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT DURING A GENERATOR REPLACEMENT SURGERY THAT HIGH IMPEDANCE WAS RECEIVED WHEN THE NEW GENERATOR WAS ATTACHED AND PLACED IN THE SURGICAL POCKET. IT IS UNKNOWN IF THE PATIENT HAD HIGH IMPEDANCE WITH THE PREVIOUS GENERATOR. THE MANUFACTURER WAS NOT CONTACTED UNTIL AFTER THE SURGEON WAS IN THE PROCESS OF SEWING THE PATIENT BACK-UP SO NO TROUBLESHOOT WAS DONE AND THE HIGH IMPEDANCE WAS NO RESOLVED. THE PATIENT HAD THE GENERATOR TURNED ON DURING SURGERY WAS BUT WAS TURNED OFF SHORTLY AFTER. REVIEW OF MANUFACTURING RECORDS CONFIRMED THERE WERE NO UNRESOLVED NON CONFORMANCES FOUND WITH THE LEAD PRIOR TO DISTRIBUTION. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT¿S FAMILY IS NOT PURSING SURGERY AT THIS TIME. THE HIGH IMPEDANCE WAS PRESENT SINCE THE PATIENT RECENT GENERATOR REPLACEMENT WHEN IT WAS ATTEMPTED TO PROGRAMMING THE PATIENT. THE PHYSICIAN WAITED A WEEK AND THE HIGH IMPEDANCE REMAINED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT UNDERWENT SURGERY IN (B)(6) 2013 AND THE LEAD PIN WAS FOUND TO BE NOT FULLY INSERTED INTO THE GENERATOR HEADER. THE SURGEON RE-INSERTED THE LEAD PIN INTO THE GENERATOR HEADER AND SUBSEQUENT DIAGNOSTIC RESULTS SHOWED NORMAL DEVICE FUNCTION. THE GENERATOR AND LEAD WERE NOT REPLACED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308566 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 202378

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR