BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2831286 · Received November 14, 2012

    Report

    Report Number
    1644487-2012-02995
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    May 1, 2012
    Report Date
    October 15, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012, THIS VNS PATIENT UNDERWENT GENERATOR REVISION DUE TO IMPROPER PLACEMENT. THE DEVICE WAS RETURNED ON (B)(6) 2012 AND IS CURRENTLY UNDERGOING PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT THIS VNS PATIENT'S DEVICE WAS PLACED THROUGH A SINGLE INCISION. WHILE THIS WAS COSMETICALLY APPEALING, IT DID NOT ALLOW GENERATOR PLACEMENT BEHIND THE TAIL OF THE BREAST. AS SUCH, IT IS NOT ONLY FREELY MOBILE, BUT ALSO JUST UNDER HER ANTERIOR CHEST SKIN AND CLEARLY CAUSING THE PATIENT DISCOMFORT. THE PATIENT BENEFITTED GREATLY FROM THE DEVICE AND ABANDONING IT IS NOT AN OPTION TO HER. AS SUCH, THE PHYSICIAN INTENDED TO PROCEED TO THE OPERATING ROOM TO CREATE A LATERAL CHEST INCISION AND MOVE THE DEVICE TO ITS TYPICAL LOCATION AND ALSO SECURELY TIE-DOWN THE DEVICE SO IT IS NOT MOBILE. NOTES DATED (B)(6) 2012 INDICATED THAT THE EVENT BEGAN SIX MONTHS AGO. THE GENERATOR COULD MOVE FREELY AND THE PATIENT COULD FLIP IT ON ITS SIDE. RECENTLY, THE DISCOMFORT BECAME WORSE. SURGERY IS LIKELY BUT HAS NOT OCCURRED.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS WAS APPROVED ON (B)(6) 2012. THE SEPTUM WAS NOT CORED, THUS ELIMINATING THE POSSIBILITY OF A POTENTIAL UNINTENDED ELECTRICAL CURRENT PATH THROUGH BODY FLUIDS. IN THE PA LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR'S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. DATA IN MEMORY LOCATIONS REVEALED THAT 3.656% OF THE BATTERY HAD BEEN CONSUMED. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 2925

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other