BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1894927 · Received November 5, 2010

    Report

    Report Number
    1644487-2010-02504
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    May 5, 2010
    Report Date
    October 7, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT A VNS PT WAS TO BE RE-IMPLANTED WITH VNS THERAPY DUE TO UNK REASON. CLINIC NOTES DATED (B)(6) 2010 WERE FURTHER RECEIVED BY THE MFR WHICH INDICATED THE PT EXPERIENCED AN INCREASE IN SEIZURE FREQUENCY. FOLLOWING NOTES FROM (B)(6) 2010 AND (B)(6) 2010 FURTHER INDICATED, THE PT EXPERIENCED STATUS EPILEPTICUS. INTERVENTIONS PLANNED AT THIS POINT WERE TO REPLACE THE PT'S GENERATOR. ADD'L INFO WAS RECEIVED FROM THE TREATING NURSE INDICATING THE PT'S DEVICE WAS PROGRAMMED OFF BY PREVIOUS TREATING NEUROLOGIST PER MOTHER'S REQUEST AS SHE INDICATED THE VNS WAS NOT HELPING THE PT. THE PT'S PREVIOUS NEURO DID BELIEVE VNS WAS WORKING BUT PROGRAMMED OFF THE PT PER MOTHER'S REQUEST. THE PT WAS TRANSFERRED TO THE OFFICE OF THE CURRENT TREATING NEUROLOGIST IN (B)(6) AND IN (B)(6), THE PT'S VNS WAS TO BE PROGRAMMED ON. MOREOVER, THE NURSE INDICATED, THE VNS WAS UNABLE TO BE INTERROGATED AND BELIEVED IT TO BE AT EOS. THE NURSE'S PROGRAMMING SYSTEM (THE ONE USED ON PT) WAS WORKING WELL AS SHE WAS ABLE TO SUCCESSFULLY INTERROGATED OTHER VNS PTS. FURTHERMORE, THE TREATING NURSE INDICATED, THE CAUSE OF THE INCREASE IN SEIZURES WAS UNK AS WELL AS PRE-VNS BASELINE. AT THE MOMENT, THE PT IS PENDING A SURGERY DATE FOR REPLACEMENT OF THE GENERATOR AS IT HAD BEEN HELPING THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention