BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2991262 · Received March 6, 2013

    Report

    Report Number
    1644487-2013-00602
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    December 1, 2012
    Report Date
    February 11, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED GENERATOR MET ALL SPECIFICATIONS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013 WHEN IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED PROPHYLACTICALLY THAT DAY. PRE-OPERATIVE DIAGNOSTICS PERFORMED REVEALED DCDC =2 WITH ERI STATUS = NO. THE EXPLANTED GENERATOR WAS RECEIVED FOR PRODUCT ANALYSIS ON (B)(4) 2013. PRODUCT ANALYSIS WAS COMPLETED ON (B)(6) 2013. 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. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS AS DEFINED IN THE FINAL ELECTRICAL TEST. DURING THE PRODUCT ANALYSIS THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    ON (B)(6) 2013 CLINIC NOTES FROM THAT DATE WERE RECEIVED. REVIEW OF THE CLINIC NOTES INDICATE THAT THE PATIENT THINKS THE VNS IS NOT WORKING WELL ANYMORE AND THAT THE PATIENT'S SEIZURE FREQUENCY IS INCREASING. THE DEVICE WAS CHECKED AND THE DCDC WAS 4. THE PHYSICIAN STATED THAT THE VNS IS OVER 6 YEARS OLD AND APPEARS TO NEED REPLACEMENT. THE PHYSICIAN LATER REPORTED THAT THE INCREASE IN SEIZURES WAS FIRST OBSERVED IN (B)(6) 2012. HE STATED THAT THE INCREASE IN SEIZURES WAS DUE TO LOSS OF THERAPY AS THE BATTERY NEEDS REPLACEMENT. THE PATIENT HAS BEEN ON 4 AEDS AS AN INTERVENTION. THE PHYSICIAN ALSO MENTIONED THAT THE SEIZURES ARE A FEW TIMES A WEEK AND THAT THE PATIENT HAD A SEIZURE AND HIT HER HEAD, REQUIRING 12 STAPLES IN HER SCALP. HE AGAIN STATED THAT THE VNS IS NOT WORKING PROPERLY. THE MANUFACTURING RECORDS FOR THE GENERATOR WERE REVIEWED AND THE DEVICE MET ALL SPECIFICATIONS PRIOR TO DISTRIBUTION. THE PHYSICIAN LATER REPORTED THAT HE IS NOT GOING TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE PATIENT. THE PHYSICIAN DID STATE HOWEVER THAT IT IS HIS OPINION THAT THE THERAPY ISN'T BEING DELIVERED WHICH IS WHY HE REFERRED THE PATIENT FOR REPLACEMENT. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96297 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 015168

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other