BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3170988 · Received June 14, 2013

    Report

    Report Number
    1644487-2013-01791
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 20, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THE DEVICE MET ALL FINAL TESTING SPECIFICATIONS PRIOR TO DISTRIBUTION. X-RAYS REVIEWED BY THE MANUFACTURER, LEAD PIN NOT FULLY INSERTED PAST THE CONNECTOR BLOCK OF THE GENERATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A BATTERY REPLACEMENT DUE TO END OF SERVICE ON (B)(6) 2013. WHILE IN THE OPERATING ROOM, THE SURGEON INTERROGATED THE PATIENT'S DEVICE THREE TIMES AND FOUND THAT EVERYTHING "LOOKED GREAT"; AND ALL TESTING WAS WITHIN NORMAL LIMITS. THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS AND THE PATIENT WAS DISCHARGED TO THE RECOVERY ROOM TO RECOVER. WHEN AN ATTEMPT WAS MADE IN THE RECOVERY ROOM TO PROGRAM THE PATIENT"S DEVICE TO HIS PREVIOUS PRE-SURGERY SETTINGS, THE FOLLOWING WARNING WAS SEEN: "PROGRAMMED CURRENT WAS NOT BEING DELIVERED TO THE PROGRAMMED LEVEL." THE PATIENT THEN BEGAN GETTING SICK AND WAS VOMITING AND COUGHING DUE TO THE STIMULATION BEING TURNED ON. THE PATIENT WAS SENT HOME AND CAME BACK ON (B)(6) 2013 TO GET THE DEVICE PROGRAMMED. IT WAS UNKNOWN IF THE PATIENT LEFT THE HOSPITAL AFTER SURGERY WITH THE DEVICE TURNED ON OR TURNED OFF. DURING THE OFFICE VISIT ON (B)(6) 2013, THE SAME WARNING MESSAGE WAS OBSERVED. DIAGNOSTIC TESTING SHOWED HIGH IMPEDANCE AND THE PATIENT WAS SENT FOR X-RAYS. THE PHYSICIAN'S ASSISTANT STATED THAT THE LEAD APPEARED FINE ON THE X-RAY; HOWEVER, THE IMAGES WERE SENT TO THE MANUFACTURER FOR REVIEW. IT WAS UNKNOWN IF THE EXPLANTED GENERATOR HAD BEEN TESTED PRIOR TO SURGERY TO CONFIRM IF THE LEAD WAS OK. THE PATIENT'S MOTHER REPORTED THAT THE PATIENT DID NOT TOLERATE THE SETTINGS VERY WELL WHEN THE PHYSICIAN TRIED TO PROGRAM THE DEVICE TO THE PRE-SURGERY SETTINGS IN THE RECOVERY ROOM. THE PATIENT "WRETCHED; AND VOMITED" SEVERAL TIMES WHILE THE NURSE WAS TRYING TO ADJUST THE SETTINGS. PER THE MOTHER, THE DEVICE WAS LEFT TURNED ON WHEN THE PATIENT WAS DISCHARGED HOME. THE PATIENT'S MOTHER STATED THAT SHE REPORTED TO THE PHYSICIAN ON (B)(6) 2013 THAT THE PATIENT WAS HAVING AN INCREASE IN SEIZURES SINCE THE REPLACEMENT. THE PHYSICIAN CHECKED THE DEVICE AND FOUND HIGH IMPEDANCE, THEN DISABLED (PROGRAMMED TO 0MA) THE DEVICE. ON (B)(6) THE PATIENT RECEIVED A CALL FROM THE PHYSICIAN'S OFFICE SAYING THAT THE X-RAYS NEEDED TO BE REPEATED AS THEY WERE NOT ACCEPTABLE. X-RAYS WERE TAKEN AGAIN ON (B)(6) 2013, AND THE MOTHER ADMITTED THAT THE PATIENT HAD A DIFFICULT TIME LYING STILL FOR THE X-RAYS THE PREVIOUS TIME AND IT WAS POSSIBLE THEY WERE NOT CLEAR. THE MANUFACTURER'S RECORDS FOR THE LEAD WERE REVIEWED AND IT WAS CONFIRMED THAT THE LEAD MET ALL FINAL TESTING SPECIFICATIONS PRIOR TO DISTRIBUTION. AP AND LATERAL VIEWS OF THE NECK AND CHEST WERE RECEIVED AND REVIEWED. THE GENERATOR IS SEEN IN NORMAL ORIENTATION IN THE LEFT CHEST AREA. THE FILTER FEEDTHRU WIRES APPEAR INTACT. DUE TO THE IMAGE QUALITY, IT CANNOT BE ASSESSED IF THE LEAD IS INTACT AT THE CONNECTOR PIN. THE LEAD PIN COULD NOT BE SEEN PAST THE SECOND CONNECTOR BLOCK, INDICATING THAT IT MAY NOT BE FULLY INSERTED INTO THE GENERATOR. THE ELECTRODES WERE OBSERVED IN THE NECK AND APPEAR TO BE IN PROPER ALIGNMENT. THERE APPEARS TO BE A SHARP BEND BEYOND THE LAST ELECTRODE. THE LEAD IS SEEN ROUTED DOWN TOWARD THE GENERATOR. A PORTION OF THE LEAD APPEARS TO BE PRESENT BEHIND THE GENERATOR AND COULD THEREFORE NOT BE ASSESSED. THE ELECTRODES WERE OBSERVED IN THE NECK AND APPEAR TO BE IN PROPER ALIGNMENT. A STRAIN RELIEF BEND IS PRESENT; HOWEVER, IT IS NOT PER LABELING AS IT BEGINS AT A SHARP BEND RIGHT WHERE THE ANCHOR TETHER SHOULD BE. THE STRAIN RELIEF LOOP APPEARED TO BE PER LABELING. TWO TIE-DOWNS WERE PRESENT. THE FIRST TIE-DOWN WAS WITHIN THE STRAIN RELIEF LOOP, WHILE THE SECOND TIE-DOWN WAS BEYOND THE STRAIN RELIEF LOOP. THERE WAS NO TIE-DOWN PLACED LATERAL TO THE ANCHOR TETHER AS LABELING SUGGESTS. SURGERY WAS SCHEDULED FOR (B)(6) 2013. A VISUAL INSPECTION OF THE LEAD FOUND NO OBVIOUS LEAD BREAKS OR FRACTURES. THE LEAD PIN WAS REMOVED AND RE-INSERTED. DIAGNOSTICS WERE PERFORMED FIVE OR SIX TIMES DURING SURGERY AND SHOWED OK RESULTS. IT IS UNKNOWN WHAT CAUSED THE HIGH IMPEDANCE, BUT THE HIGH IMPEDANCE WAS RESOLVED. THE PATIENT'S DEVICE WAS NOT REPLACED. ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION; HOWEVER, THEY HAVE BEEN UNSUCCESSFUL. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270562 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 3382

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR