BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3021114 · Received March 26, 2013

    Report

    Report Number
    1644487-2013-00805
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 25, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2013 REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW-UP AS HE WAS HAVING MORE SEIZURES. THE PATIENT HAS TRIED MANY MEDICATIONS FOR THE SYMPTOMATIC GENERALIZED EPILEPSY OF UNCERTAIN ETIOLOGY. THE VNS PROGRAMMING SETTINGS WERE REDUCED BY CHANGING THE OFF TIME TO 3 MINUTES, AND ONE OF THE PATIENT'S MEDICATION DOSAGE WAS INCREASED WHILE THE OTHERS REMAINED THE SAME. THE BATTERY WAS REPORTEDLY LOW AND "ALMOST DEPLETED". THEREFORE, THE PATIENT WAS REFERRED FOR GENERATOR REPLACEMENT. ATTEMPTS FOR ADDITIONAL INFORMATION TO THE TREATING PHYSICIAN HAVE BEEN UNSUCCESSFUL TO DATE. THE BELIEVED CAUSE OF THE INCREASED IN SEIZURES IS UNKNOWN. IN ADDITION, ATTEMPTS TO MEDICAL RECORDS FOR DEVICE PRODUCT INFORMATION HAVE BEEN UNSUCCESSFUL THUS FAR. THE PATIENT HAD GENERATOR REPLACEMENT SURGERY ON (B)(6) 2013. ATTEMPTS FOR PRODUCT RETURN ARE UNDERWAY, BUT THE DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE.

    Description of Event or Problem · 1

    THE GENERATOR WAS RECEIVED FOR ANALYSIS. ANALYSIS OF THE GENERATOR WAS COMPLETED ON (B)(4) 2013. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    THE IMPLANT CARD REPORTED THE REASON FOR GENERATOR REPLACEMENT ON (B)(6) 2013 AS 'DEAD GENERATOR.' FOLLOW UP WITH THE HOSPITAL FACILITY REVEALED THAT THE EXPLANTED DEVICE HAS LEFT THE LAB TO DATE. THE PRODUCT HAS NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE. ATTEMPTS FOR PRODUCT INFORMATION FROM MEDICAL RECORDS HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124485 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 200867

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention