BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3782063 · Received April 30, 2014

    Report

    Report Number
    1644487-2014-01148
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 2, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2014 NOTE THAT THE PATIENT WAS SEEN IN CLINIC ON (B)(6) 2014 DUE TO AN INCREASED FREQUENCY OF SEIZURES OF LONG DURATION. IT WAS REPORTED THAT DEVICE INTERROGATION SHOWED THE GENERATOR APPROACHING END OF SERVICE. A COMPANY REPRESENTATIVE WAS NOTIFIED AND WAS PRESENT AT THE PATIENT'S NEXT VISIT. THE NOTES INDICATE THAT THE DEVICE INTERROGATION SHOWED NORMAL DIAGNOSTICS. THE DEVICE WAS REFERRED FOR REPLACEMENT SURGERY. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. NO SURGICAL INTERVENTION HAS BEEN PERFORMED TO DATE.

    Description of Event or Problem · 1

    ANALYSIS OF THE GENERATOR WAS COMPLETED ON (B)(4) 2014. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE GENERATOR SHOWS AN IFI CONDITION. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED INDICATING THAT THE VNS PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014 DUE TO IFI = YES. THE EXPLANTED GENERATOR HAS BEEN RETURNED TO THE GENERATOR WHERE ANALYSIS IS CURRENTLY UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260608 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 2714

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention