BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2101953 · Received May 18, 2011

    Report

    Report Number
    1644487-2011-01112
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, LEAD PIN NOT FULLY INSERTED PAST THE CONNECTOR BLOCK OF THE GENERATOR.

    Description of Event or Problem · 1

    ON (B)(6) 2011, IT WAS REPORTED BY A VNS TREATING NEUROLOGIST'S REGISTERED NURSE, THAT THE VNS PT PRESENTED WITH HIGH IMPEDANCE THAT DAY WITH LEAD IMPEDANCE GREATER THAN 10000 OHMS. THE PT HAD THEIR BATTERY REPLACED IN (B)(6) 2010, AND ON (B)(6) 2011, THE PT CAME IN AND SYSTEM DIAGNOSTICS WERE RUN, WITH OUTPUT STATUS = OK, LEAD IMPEDANCE = OK OF 2406 OHMS, AND IFI = NO. THE DEVICE WAS DISABLED ON (B)(6) 2011, AND X-RAYS WERE TAKEN. THE NURSE REPORTED THAT NO OBVIOUS LEAD BREAKS WERE OBSERVED, BUT THEY DID SEE "KINKS" IN THE LEAD WIRE IN A COUPLE OF DIFFERENT SPOTS. THEY REFERRED THE PT FOR SURGERY TO REPLACE THE WHOLE SYSTEM. THE PT IS ALSO HAVING AN INCREASE IN SEIZURES, BUT IT IS UNK IF THEY ARE ABOVE OR BELOW PRE-VNS BASELINE LEVELS. THE PT'S MOM DENIES ANY TRAUMA TO THE PT'S DEVICE, BUT THE NURSE SAID THAT THE PT IS VERY ACTIVE. AP AND LATERAL X-RAY VIEWS OF THE CHEST AND NECK WERE RECEIVED FOR REVIEW ON (B)(6) 2011. BASED ON THE VIEWS RECEIVED, IT APPEARED THAT A POSSIBLE INCOMPLETE PIN INSERTION COULD BE CONTRIBUTING TO THE OBSERVED HIGH IMPEDANCE. HOWEVER, AN UNPRONOUNCED LEAD FRACTURE OR DISCONTINUITY CANNOT BE RULED OUT. CLINIC NOTES WERE RECEIVED FROM THE PHYSICIAN AND REVIEW OF THE CLINIC NOTES DATED (B)(6) 2011, STATE THAT THE VNS PT WAS HOSPITALIZED IN (B)(6) 2011, FOR SEIZURE ACTIVITY AND A PROLONGED POSTICTAL STATE. A WORKUP DONE AT THE TIME WAS UNREMARKABLE. A MONTH AGO, THE PT HAD MONONUCLEOSIS AND WITH IT, HAD A MARKED INCREASE IN HER SEIZURE ACTIVITY. THE PT WAS ALSO SEEN FOR AN UPPER RESPIRATORY INFECTION AND EAR INFECTION AT THAT TIME. THE PHYSICIAN STATES THAT HE WONDERS IF THE INCREASE IN SEIZURE ACTIVITY IS SECONDARY TO THE VNS BEING DISCONNECTED. ON (B)(6) 2011, THE PT WENT FOR SURGERY. DURING PRE-OP INTERROGATION, DIAGNOSTICS WERE WITHIN NORMAL LIMITS OF 3000OHMS BUT SURGERY CONTINUED. THE HOSPITAL REPORTED THAT DURING SURGERY, ONLY THE PT'S GENERATOR WAS REPLACED. EXPLANTED PRODUCT RETURN HAS BEEN REQUESTED FROM THE HOSPITAL, BUT IT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. WHEN ADDITIONAL INFO IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 2839

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention