BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 100

    MDR report key: 2133608 · Received June 16, 2011

    Report

    Report Number
    1644487-2011-01362
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 21, 2011
    Report Date
    May 17, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURE FROM EXPLANTING PHYSICIAN IN (B)(6) THAT HE HAD A PATIENT WITH LACK OF EFFICACY WITH THEIR VNS THERAPY AND WHO WAS HAVING PAIN AT THEIR GENERATOR SITE, LEFT INFRACLAVICULAR. IN THE LAST 2 YEARS, THE PATIENT HAD EXPERIENCED PAIN IN THE AREA OF THE GENERATOR IN THE LEFT INFRACLAVICULAR AND AXILLARY REGIONS. THE GENERATOR HAD BEEN TURNED OFF FOR 3 YEARS DUE TO BATTERY EXHAUSTION. THE PATIENT INSISTED ON HAVING THEIR VNS SYSTEM EXPLANTED RELATED TO THEIR PAIN EVENTS. IT IS UNKNOWN IF THIS SURGERY WAS FOR PATIENT COMFORT OR TO PRECLUDE A SERIOUS INJURY TO THE PATIENT. DURING THE EXPLANT PROCEDURE AT A DEPTH OF ABOUT 1.5 CM, THE FIRST SECURING CLIP WAS FOUND. THE SUTURE WAS DETACHED AND THE CLIP DISSECTED FROM THE FIBRIN SHEATH. THE CABLE WAS FOLLOWED IN THE PROXIMAL DIRECTION AND THE NEXT SECURING CLIP FOUND AFTER 1 CM AT THE LEVEL OF THE CAROTID. HERE, THE SUTURE OF THE SECURING CLIP HAD PIERCED THE ADVENTITIA OF THE CAROTID ARTERY. THE FIBRIN SHEATH SURROUNDED THE SECURING CLIP, FORMING A CUFF ON THE CAROTID. SINCE THE STIMULATOR CABLE RAN THROUGH A SCAR BETWEEN THE JUGULAR AND CAROTID ARTERIES INTO THE DEPTHS, DISSECTION WAS ATTEMPTED HERE AS WELL. THE PROJECT HAD TO BE ABORTED, HOWEVER, BECAUSE IT WAS TOO RISKY, AND BOTH THE CAROTID AND THE JUGULAR COULD HAVE BEEN INJURED. THEIR EXPLANTED GENERATOR WAS RETURNED FOR ANALYSIS. IN THE PRODUCT ANALYSIS LABORATORY, IT WAS DETERMINED THAT THE DEVICE WAS AT AND END OF SERVICE CONDITION; AN OPEN CAN MEASUREMENT OF THE BATTERY VOLTAGE CONFIRMED THAT THE BATTERY WAS DEPLETED. BASED ON THE BENCH ANALYSIS AND THE ELECTRICAL TEST RESULTS, THE DEVICE EXHIBITED CURRENT CONSUMPTION RATES THAT WERE WITHIN SPECIFICATION; THEREBY, DEMONSTRATING NORMAL BATTERY DEPLETION TO AN END OF SERVICE CONDITION. NO PROGRAMMING HISTORY RECORDS WERE FOUND; CONSEQUENTLY, A BATTERY LIFE CALCULATION COULD NOT BE PERFORMED. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATION. THEREFORE, THE ELECTRICAL PERFORMANCE OF THE GENERATOR, AS MEASURED IN THE PRODUCT ANALYSIS LABORATORY, WILL BE USED TO CONCLUDE THAT NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND WITH THE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 100 LYJ CYBERONICS, INC. 100 23074C

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| R