BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3122496 · Received May 21, 2013

    Report

    Report Number
    1644487-2013-01508
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 23, 2013
    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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN. THE PATIENT HAD BEEN LOST TO FOLLOW-UP AND THEN WAS SEEN IN THE HOSPITAL. THE GENERATOR WAS UNABLE TO BE INTERROGATED AT THAT TIME BELIEVED TO BE DUE TO END OF LIFE. THE PHYSICIAN FEELS THIS IS A COMPLIANCE ISSUE WITH THE PATIENT AND NOT A DEVICE ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO A FLURRY OF SEIZURES. IT IS UNCLEAR IF THIS WAS AN INCREASE FOR THE PATIENT OR PART OF HER NORMAL SEIZURE PATTERN. THE PATIENT HAD NOT HAD HER VNS CHECK IN SOME TIME AND ADMITS TO BEING NON-COMPLIANT. THE PATIENT HAD A GENERATOR REPLACEMENT. THE EXPLANTED PRODUCT WAS DISCARDED AND WILL NOT BE RETURNED TO THE MANUFACTURER FOR REVIEW. GOOD FAITH ATTEMPT FOR ADDITIONAL INFORMATION HAS BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ON (B)(4) 2013 IT WAS REPORTED THAT THE MANUFACTURER¿S CONSULTANT CHECKED OUT THE PHYSICIAN¿S PROGRAMMING SYSTEM AND IT IS ABLE TO INTERROGATE. THE PHYSICIAN LATER REPORTED THAT HE RECALLED HAVING TO CHANGE THE 9V BATTERY BEFORE TRYING TO INTERROGATE THE PATIENT, AND THEN NOT HAVING SUCCESS. HE STATED THAT HE HEARD THAT UPON RE-INTERROGATION, THEY WERE ABLE TO SUCCESSFULLY INTERROGATE THE PATIENT. HE HAS SUCCESSFULLY USED THE PROGRAMMING SYSTEM MANY TIMES SINCE THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223734 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 200975

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention