BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3900196 · Received June 27, 2014

    Report

    Report Number
    1644487-2014-01613
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 29, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014 DUE TO PAIN AND REPOSITIONING OF THE GENERATOR POCKET. THE EXPLANTED GENERATOR WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. MONITORING OF THE DEVICE OUTPUT SIGNAL SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. THE SEPTUM WAS NOT CORED, THUS ELIMINATING THE POSSIBILITY OF A POTENTIAL UNINTENDED ELECTRICAL CURRENT PATH THROUGH BODY FLUIDS. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. DURING THE PRODUCT ANALYSIS, THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED NECK PAIN AND "INTERMITTENT BUZZING", WHICH STARTED BACK IN 2014. THE BUZZING SENSATION STOPPED WHEN THE PATIENT'S GENERATOR WAS REPLACED IN 2014 BUT THE NECK DISCOMFORT CONTINUED TO BE PRESENT. THE PATIENT CONTINUES TO HAVE PAIN WHEN TURNING THE NECK. IT IS UNKNOWN WHETHER THE NECK PAIN IS RELATED TO VNS. IT WAS REPORTED BY THE PATIENT'S CAREGIVER THAT IT COULD BE RELATED TO A MUSCLE STRAIN. NO KNOWN INTERVENTIONS WERE TAKEN REGARDING NECK PAIN AS PATIENT HAS NOT CONSULTED A PHYSICIAN REGARDING THIS YET.

    Description of Event or Problem · 1

    FURTHER FOLLOW UP INDICATED THAT THE X-RAYS APPEARED NORMAL AND THE VNS DEVICE DIAGNOSTICS WERE ALSO NORMAL. AS THE PATIENT IS HARD TO COMMUNICATE WITH, THE CAUSE OF THE PAIN REMAINS UNKNOWN AND VNS WAS NOT RULED OUT TO BE A POSSIBLE FACTOR. THE X-RAYS WERE RECEIVED AND REVIEWED BY THE MANUFACTURER. TWO SETS OF ELECTRODES WERE VISUALIZED IN THE NECK REGION. THE SUPERIOR SET OF ELECTRODES PERTAINS TO THE CURRENT FUNCTIONAL LEAD THAT WAS IMPLANTED ON (B)(6) 2009 AND THE INFERIOR SET OF ELECTRODES BELONGS TO THE LEAD THAT WAS PARTIALLY EXPLANTED ON 09/10/2009. THERE DID NOT APPEAR TO BE ANY GROSS FRACTURES OR DISCONTINUITIES THAT MIGHT EXPLAIN THE PAIN AND PAINFUL STIMULATION.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2014 NOTE THAT THE PATIENT HAS EXPERIENCED A STINGING SENSATION AT THE GENERATOR SITE. IT WAS NOTED THAT THE PATIENT FEELS THAT THE DEVICE IS STILL WORKING. IT WAS NOTED THAT THE PATIENT'S MOTHER FEELS LIKE THE GENERATOR IS SLIPPING LOWER. IT WAS NOTED THAT THE VNS IS CAUSING THE PATIENT PAIN FOR THE LAST MONTH AND THAT IT SEEMS TO BE SLIPPING DOWN IN HER CHEST. X-RAYS WERE PERFORMED WHICH SHOWED THE GENERATOR AT THE LEFT HEART BORDER. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. NO SURGICAL INTERVENTION HAS BEEN PERFORMED TO DATE.

    Description of Event or Problem · 1

    THE PAIN ON THE LEFT SIDE OF THE NECK WAS REPORTED TO HAVE STARTED A YEAR AGO AND IS NOT OCCURRING WITH VNS STIMULATION. PATIENT WAS ALSO REPORTED TO BE WHEEL CHAIR BOUND. IT WAS NOTED THAT THE PATIENT WOULD OFTEN TURN THE HEAD TO THE RIGHT AND STRETCH. X-RAYS WERE REVIEWED BY THE PHYSICIAN AND THE LEAD WAS OBSERVED TO BE COILED OVER THE BASE OF THE LEFT NECK AND IN THE MID LEFT NECK REGION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377867 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 2323

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention