BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2930499 · Received January 28, 2013

    Report

    Report Number
    1644487-2013-00218
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE.X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT VNS PLACEMENT SURGERY ON (B)(6) 2015. A NEW LEAD AND GENERATOR WERE PLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT WAS EXPERIENCING SIGNS OF "GENERATOR LEAKAGE". THE PHYSICIAN REPORTED THAT THE PATIENT WAS EXPERIENCING THE SAME SYMPTOMS AS THE PATIENT EXPERIENCED IN 2011 THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT FOR (REFERENCE MFR. REPORT # 1644487-2011-01472). THE PHYSICIAN INDICATED THAT THE PATIENT IS EXPERIENCING A CONSTANT TINGLING AND BURNING SENSATION AROUND THE GENERATOR WITH THE NEW GENERATOR. THE PHYSICIAN REPORTED THAT DIAGNOSTIC TESTING WAS "OK". X-RAYS WERE TAKEN AND SENT TO DEVICE MANUFACTURER FOR REVIEW. NO GROSS LEAD FRACTURES WERE VISUALIZED; HOWEVER, THE PRESENCE OF AN UNPRONOUNCED LEAD DISCONTINUITY CANNOT BE RULED OUT. THE PATIENT MAY BE SENT FOR SURGICAL CONSULT; HOWEVER, NO APPOINTMENTS HAVE BEEN SCHEDULED AT THIS TIME. IT IS UNKNOWN WHAT THE PHYSICIAN MEANS BY "GENERATOR LEAKAGE". ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE PATIENT HAS BEEN SCHEDULED FOR SURGICAL CONSULT. SURGERY IS LIKELY; HOWEVER, HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    FURTHER FOLLOW-UP REVEALED THAT THE PHYSICIAN DESCRIBED THE "GENERATOR LEAKAGE" AS A DISCOMFORT SENSATION LIKE SMALL SHOCKS AND ITCHING. THE PHYSICIAN REPORTED THAT HE HAS NOT SEEN THE PATIENT AGAIN FOR FOLLOW-UP. IT WAS REPORTED THAT THE PATIENT DID NOT SHOW UP FOR THE SURGICAL CONSULT. SURGERY MAY OCCUR IN THE FUTURE; HOWEVER, IT HAS NOT OCCURRED TO DATE. IT WAS REPORTED THAT THE PATIENT MOVED TO A DIFFERENT STATE.

    Description of Event or Problem · 1

    THE EXPLANT HOSPITAL REPORTED THAT THE GENERATOR IS NOT AVAILABLE TO RETURN TO THE MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT IT WAS KNOWN BEFORE HE MOVED THAT HE HAD A BROKEN WIRE IN HIS NECK. THE PATIENT REPORTED THAT HE WAS SEEN BY A NEUROSURGEON WHO RECOMMENDED REMOVAL OF THE VNS SYSTEM AFTER THE CONSULTATION AND REVIEW OF THE PATIENT'S PREVIOUS MEDICAL RECORDS. IT IS UNKNOWN IF DEVICE DIAGNOSTICS WERE PERFORMED AT THE CONSULTATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON. IT WAS REPORTED THAT THE DEVICE WAS ALSO EXPLANTED (NOT REPLACED) DUE TO MIGRATION ON (B)(6) 2014 FOR PATIENT COMFORT. IT WAS UNKNOWN WHEN THE WEIGHT LOSS AND SUBSEQUENT DEVICE MIGRATION BEGAN. THE GENERATOR AND PORTION OF THE LEAD WERE REMOVED ON (B)(6) 2014. THE MIGRATION EVENT WAS ALSO PREVIOUSLY REPORTED IN MFG REPORT # MFG REPORT #: 1644487-2013-00218, WHICH HAS SINCE BEEN DETERMINED THROUGH THE NEW INFORMATION RECEIVED TO BE RELATED TO THE EVENTS IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT VNS REMOVAL DUE TO PAIN, BURNING AND DISCOMFORT. GOOD FAITH ATTEMPTS FOR ADDITIONAL, RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36454 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 2744

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other