BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 6858979 · Received September 12, 2017

    Report

    Report Number
    1644487-2017-04445
    Event Type
    Injury
    Date Received
    September 12, 2017
    Date of Event
    January 1, 2017
    Report Date
    November 3, 2017
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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

    IT WAS REPORTED THAT THE PATIENT HAS BEEN HAVING SEIZURES UP TO 2 TIMES PER WEEK. THE DOCTOR NOTED THAT SHE HAS HAD INCREASED SEIZURE FREQUENCY SINCE HER VNS HAS NOT BEEN WORKING WELL. THE PATIENT SAID THE BATTERY HAS NOT BEEN CHANGED SINCE 2008, BUT A BLC WAS RUN, INDICATING 5 YEARS UNTIL NEOS (NEAR END OF SERVICE). LASTLY IT WAS REPORTED THAT THE PATIENT MAY NEED A NEW BATTERY. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO KNOWN SURGICAL INTERVENTIONS FOR VNS HAS OCCURRED TO DATE.

    Description of Event or Problem · 1

    THIS PATIENT HAS RECEIVED A PROPHYLACTIC GENERATOR REPLACEMENT. THE EXPLANTED PRODUCT HAS NOT BEEN RECEIVED TO DATE AND THE EXPLANT HOSPITAL'S PROTOCOL IS NORMALLY TO DISCARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638968 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 200790

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention