BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2102387 · Received May 20, 2011

    Report

    Report Number
    1644487-2011-01142
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, A VNS TREATING PHYSICIAN REPORTED THAT HE WAS UNABLE TO INTERROGATE THE VNS PT'S GENERATOR. THE PT IS ALSO EXPERIENCING AN INCREASE IN SEIZURES. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY INTERROGATE OTHER PTS WITH THE PROGRAMMING SYSTEM AFTER THE INTERROGATION ISSUE WITH THE PT. THEY CHANGED THE BATTERY IN THE WAND AS PART OF TROUBLESHOOTING AND IT DID NOT RESOLVE THE GENERATOR FAILING TO PROGRAM. THE PT HAS BEEN REFERRED FOR BATTERY REPLACEMENT. THE PHYSICIAN REPORTED THAT IT IS UNK WHEN THE INCREASE IN SEIZURES WAS FIRST OBSERVED. HE SAID THAT THE RELATIONSHIP OF THE INCREASE IN SEIZURES TO PRE-VNS BASELINE LEVELS IS UNK, BUT LIKELY BACK TO OR ABOVE PRE-VNS LEVELS. NO CAUSAL OR CONTRIBUTORY PROGRAMMING CHANGES, MEDICATION CHANGES, OR OTHER EXTERNAL FACTORS PRECEDED THE ONSET OF THE INCREASE IN SEIZURES. THE PHYSICIAN REPORTED THAT THE PT'S MOST RECENT SYSTEM DIAGNOSTICS WERE RUN (B)(6) 2010 WHICH SHOWED OUTPUT = OK/LEAD IMPEDANCE = OK/DCDC = 1/ERI = NO. A BATTERY LIFE CALCULATION WAS PERFORMED WITH THE PT'S PROGRAMMING HISTORY WHICH REVEALED NEGATIVE YEARS UNTIL ERI = YES. SURGERY IS LIKELY BUT HAS NOT YET BEEN SCHEDULED. WHEN ADD'L INFO IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 9728

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR