BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2871153 · Received December 12, 2012

    Report

    Report Number
    1644487-2012-03308
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE PATIENT IS NO LONGER CONSIDERING EXPLANT SURGERY AT THIS TIME, AS THE PHYSICIAN WILL NOT REPLACE THE GENERATOR UNTIL THE ERI=YES FLAG IS SEEN. A REVIEW OF PROGRAMMING HISTORY FOUND THE PATIENT'S MOST CURRENT DIAGNOSTIC RESULTS FROM 2009. A BATTERY LIFE CALCULATOR INDICATED 1.23 YEARS UNTIL END OF SERVICE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT THE PATIENT WILL BE SEEING THE PHYSICIAN FOR POSSIBLE END OF SERVICE OF DEVICE AND AN INCREASE IN SEIZURES. FOLLOW UP WITH THE PHYSICIAN'S OFFICE FOUND THAT THE PATIENT IS ON SIX ANTI-EPILEPTIC DRUGS AND HAS VNS, BUT DOES NOT USE THE MAGNET. IT WAS QUOTED FROM THE CLINIC VISIT REPORT THAT THE PATIENT AND HER MOTHER REPORT THAT SURGICAL OPTIONS HAVE BEEN DISCUSSED WITH THEM SEVERAL TIMES BUT THEY ARE NOT INTERESTED IN ANY INVASIVE PROCEDURES AT THIS TIME. BASED ON THIS, THE NURSE STATED THAT SHE DOES NOT BELIEVE THE PATIENT IS CURRENTLY CONSIDERING RE-IMPLANT SURGERY. THERE WERE NO NOTES TO INDICATE IF THE PHYSICIAN CHECKED IF THE DEVICE WAS AT END OF SERVICE OR NOT. THE NURSE STATED THAT SHE WOULD CONTACT THE VNS REPRESENTATIVE IF ANY FURTHER INFORMATION IS FOUND; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. NO FURTHER INFORMATION IS AVAILABLE IN REGARDS TO THE PATIENT'S SEIZURES AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 GENERATOR LYJ CYBERONICS, INC. 101 4533

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other