BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 384225 · Received March 22, 2002

    Report

    Report Number
    1644487-2002-00108
    Event Type
    Injury
    Date Received
    March 22, 2002
    Date of Event
    February 1, 2002
    Report Date
    February 21, 2002
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE PATIENT FEELS BOTH NORMAL AND MAGNET MODE STIMULATION; HOWEVER, THE SITE COULD NOT COMMUNICATE WITH THE DEVICE (DATA TRANSMISSION ERROR). ATTEMPTS TO RESET THE PATIENT'S DEVICE WERE UNSUCCESSFUL. A DEMO DEVICE WAS SUCCESSFULLY RESET USING THE SAME PROGRAMMING SYSTEM. IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED SUBCUTANEOUSLY AS RECOMMENDED IN DEVICE LABELING. FURTHER FOLLOW-UP REVEALED THAT THE PATIENT EXPERIENCED A GENERALIZED SEIZURE A FEW DAYS PRIOR TO 03/2002. IT WAS REPORTED THAT THE LAST DIAGNOSTIC TESTING PERFORMED ON THE PATIENT'S DEVICE RESULTED IN ERI (ELECTIVE REPLACEMENT INDICATOR) FLAG WAS NO, INDICATING THAT THE GENERATOR WAS NOT AT END OF SERVICE. ADDITIONALLY, LEAD IMPEDANCE WAS WITHIN NORMAL LIMITS INDICATING PROPER DEVICE FUNCTION. THE DATE OF THIS DIAGNOSTIC TESTING IS UNKNOWN. ADDITIONAL ATTEMPTS TO INTERROGATE AND RESET THE DEVICE WERE AGAIN UNSUCCESSFUL 3 DAYS LATER, IT WAS REPORTED THAT THE PATIENT'S PROGRAMMED PARAMETERS WERE DECREASED IN 07/2001 BECAUSE THE PATIENT FELT THAT THEY WERE TOO STRONG. IT WAS REPORTED THAT SINCE THE PARAMETER REDUCTION THE PATIENT HAS BEEN VERY COMFORTABLE AND SEIZURE FREE UP UNTIL THE TIME OF THE REPORTED EVENT. IN 03/2002, IT WAS REPORTED THAT THE PATIENT HAD NOT FELT STIMULATION SINCE 02/2002 AND HAS HAD "HORRIBLE" SEIZURE CONTROL. IT WAS ALSO REPORTED THAT THE PATIENT'S MIGRANES HAD RETURNED AND THAT IN 02/2002 OFFICE VISIT THE PATIENT REPORTED TO THE DOCTOR THAT THEY BELIEVED THAT THE DEVICE HAD MIGRATED. X-RAYS WERE TAKEN TO EVALUATE DEVICE POSITIONING. X-RAY RESULTS ARE UNKNOWN AT THIS TIME. THE PATIENT HAS BEEN REFERRED TO A NEUROSURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 101 1671

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening DATE OF MFG 11/27/2000, STERLIZATION LOT NO. 1596,| 200MG, BID.| ANTI-EPILEPTIC MEDICATION: AMITRIPTYLINE 10MG,| PRN, CORGARD 40MG, PRN: ZOMIG 2.5MG, QD: CARBATROL| MODEL 300-20 NCP BIPOLAR LEAD, EXPLANTED:| 5/13/2002.| MODEL 300-20 NCP BIPOLAR LEAD EXPIR DATE 11/3/2002