BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 5357895 · Received January 11, 2016

    Report

    Report Number
    1644487-2016-00053
    Event Type
    Injury
    Date Received
    January 11, 2016
    Date of Event
    April 1, 2015
    Report Date
    December 16, 2015
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CYBERONICS, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA.

    Description of Event or Problem · 1

    CLINIC NOTES DATED WERE RECEIVED INDICATING THAT A PATIENT WAS BEING REFERRED FOR GENERATOR REPLACEMENT SURGERY DUE TO THE BATTERY REACHING END OF LIFE AND THAT THE PATIENT HAD EXPERIENCED AN INCREASE IN SEIZURES DUE TO THE DEPLETED BATTERY. A BLC PERFORMED WITH VERY LIMITED DATA INDICATED 0.7 YEARS REMAINING UNTIL NEOS = YES. THE PATIENT UNDERWENT GENERATOR REPLACEMENT. THE EXPLANTED GENERATOR WAS RETURNED FOR PRODUCT ANALYSIS WITH A STATED REASON FOR EXPLANT OF BATTERY DEPLETION. PRODUCT ANALYSIS FOUND NO ANOMALIES WITH THE PULSE GENERATOR. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS AND DID NOT SHOW A LOW BATTERY CONDITION. SUBSEQUENT FOLLOW-UP WITH THE TREATING NEUROLOGIST INDICATED NO OTHER KNOWN CAUSE FOR THE INCREASE IN SEIZURES OTHER THAN THE END OF SERVICE CONDITION THEY BELIEVED EXISTED. THE PATIENT'S CAREGIVER STATED THAT SHE THOUGHT THE INITIAL INCREASE IN SEIZURES WAS ABOVE THE PATIENT'S PRE-VNS SEIZURE RATE AND STATED THAT SINCE THE TIME OF GENERATOR REPLACEMENT THE PATIENT HAS NOT EXPERIENCED ANY SEIZURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15760 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS - HOUSTON 102 200812

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention