BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2895337 · Received January 3, 2013

    Report

    Report Number
    1644487-2013-00039
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    October 1, 2012
    Report Date
    December 6, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT ONE OF HIS PATIENT'S WAS HAVING PAIN AT THE VNS GENERATOR POCKET LOCATED IN THE PATIENT'S CHEST FOR THE PAST THREE WEEKS PRIOR TO THE APPOINTMENT ON (B)(6) 2012 AND THAT THIS PAIN HAS BEEN PROGRESSIVELY WORSENING. THERE WAS NO KNOWN TRAUMA, REPETITIVE MOVEMENTS, AND THE PHYSICIAN DID NOT FEEL LIKE THE VNS DEVICE HAS MOVED. THE PAIN IS SAID TO OCCUR CONTINUOUSLY AND DID NOT RESOLVE WHEN THE DEVICE WAS PROGRAMMED OFF. PER THE PHYSICIAN, DEVICE DIAGNOSTICS WERE PERFORMED AND THE RESULTS WERE WITHIN NORMAL LIMITS HOWEVER THE SPECIFIC DIAGNOSTIC RESULTS WERE NOT AVAILABLE AT THE TIME OF THE INITIAL REPORT. ON (B)(6) 2012 IT WAS REPORTED THAT THE PATIENT HAD BEEN SEEN AGAIN AND THE VNS DEVICE WOULD BE REPLACED DUE TO THE PAIN AT THE GENERATOR SITE. THE CAUSE OF THE PAIN WAS UNKNOWN HOWEVER THE PHYSICIAN FELT IT COULD POSSIBLY BE DUE TO PATIENT GROWTH SINCE THE DEVICE WAS INITIALLY IMPLANTED. CLINIC NOTES WERE RECEIVED ON (B)(6) 2012 FROM AN OFFICE VISIT ON (B)(6) 2012 WHERE IT WAS REPORTED THAT THE SURGEON BELIEVED THE VNS GENERATOR HAS MOVED. THE PATIENT WAS PRESCRIBED 600 MG OF IBUPROFEN FOR THE PAIN HOWEVER IF THE PAIN DID NOT IMPROVE, THE DEVICE WOULD BE REPLACED. FOLLOW UP WITH THE SURGEON'S OFFICE REVEALED THAT A NON-ABSORBABLE SUTURE WAS USED TO SECURE THE GENERATOR TO THE FASCIA. (B)(4) ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE HOWEVER THE PATIENT IS SCHEDULED FOR SURGERY HOWEVER IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 INDICATING THAT THE PATIENT UNDERWENT A GENERATOR REVISION ON (B)(6) 2013. THE IMPLANT CARD WHICH WAS RECEIVED INDICATING THAT THE LEAD IMPEDANCE WAS OK AND THAT THE REASON FOR THE REVISION WAS BOTH PROPHYLACTIC AND DUE TO THE PATIENT'S PAIN AT THE GENERATOR SITE. ATTEMPTS FOR PRODUCT RETURN OF THE GENERATOR REVEALED THAT IT HAD BEEN DISCARDED PER THE HOSPITAL POLICY. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE REMAINED UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3695 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 015709

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention