BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3011126 · Received March 19, 2013

    Report

    Report Number
    1644487-2013-00733
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 1, 2012
    Report Date
    February 21, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN THE PRODUCT ANALYSIS LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR'S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS AS DEFINED IN FINAL ELECTRICAL TEST. DURING THE PRODUCT ANALYSIS THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    THE PATIENT'S GENERATOR WAS RETURNED FOR ANALYSIS AND COMPLETION IS PENDING. BASED ON AN INTERNAL BATTERY LIFE CALCULATION THEIR DEVICE SHOULD HAVE APPROXIMATELY 0.99 YEARS TILL AT ERI YES. THE BATTERY WAS REPORTED TO BE A PROPHYLACTIC BATTERY REPLACEMENT.

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED FOR REVIEW. IT WAS NOTED ((B)(6) 2012), SHE HAS DONE WELL IN TERMS OF HER SEIZURE ACTIVITY AND IN THE LAST 3 MONTHS HAS ONLY HAD ONE SEIZURE AFTER WE HAD INCREASED THE KEPPRA DOSE. CLINIC NOTE DATED ((B)(6) 2013), IT REPORTED THAT THE PATIENT HAS A LONG HISTORY OF INTRACTABLE SEIZURE DISORDER AND UNDERWENT PLACEMENT OF VAGAL NERVE STIMULATOR ABOUT 10 YEARS AGO. THE STIMULATOR APPARENTLY PROVIDED THE PATIENT SIGNIFICANT IMPROVEMENT IN HER FREQUENCY AND SEVERITY OF SEIZURES. OVER THE LAST YEAR, THE GENERATOR IS REACHING ITS END OF LIFE SERVICE, AND THE PATIENT IS NOTICING THAT IT IS NOT STIMULATING CORRECTLY. SHE HAS ALSO BEEN HAVING AN INCREASED FREQUENCY OF SEIZURES RECENTLY. AFTER REVIEWING THE PATIENT'S HISTORY AND COMPLETING AN EXAMINATION THEIR NEUROLOGIST BELIEVES THAT HER VAGAL NERVE STIMULATOR HAS REACHED ITS END OF SERVICE WHICH IS TYPICALLY 10 YEAR TIME. THE PATIENT WOULD BE REFERRED TO SURGERY. THE ACTUAL EVENT DATE OF THIS PATIENT'S ONSET OF INCREASED SEIZURES IS UNKNOWN. IT IS UNKNOWN IF ABOVE OR BELOW THEIR PRE VNS SEIZURE RATE AND RELATIONSHIP TO THEIR THERAPY. THE PATIENT'S TREATING PHYSICIAN WILL NOT RELEASE ANY FURTHER INFORMATION. THE PATIENT HAD SURGERY AND THEIR EXPLANTED GENERATOR IS BEING RETURNED FOR ANALYSIS. THEIR GENERATOR WAS NOT AT END OF BATTERY LIFE. PREOPERATIVE DIAGNOSTICS PRIOR TO EXPLANT WERE OUTPUT STATUS OK, LEAD IMPEDANCE OK, DCDC 2, ERI NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114685 PULSE GEN MODEL 102 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 8434

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR