BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 3172667 · Received June 17, 2013

    Report

    Report Number
    1644487-2013-01797
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    July 10, 2012
    Report Date
    May 23, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2013 PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. 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. ANALYSIS IN THE PA LAB CONCLUDED PROPER FUNCTIONALITY OF THE PULSE GENERATOR AND THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND.

    Description of Event or Problem · 1

    ON (B)(4) 2013 THE EXPLANTED GENERATOR WAS RECEIVED FOR PRODUCT ANALYSIS. PRODUCT ANALYSIS IS CURRENTLY UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    ON (B)(4) 2013 CLINIC NOTES FROM A VNS TREATING PHYSICIAN WERE RECEIVED. REVIEW OF THE CLINIC NOTES DATED (B)(6) 2012 INDICATE THAT THE PATIENT WAS HAVING AN INCREASE IN SEIZURES. IT WAS STATED THAT HE CONTINUES TO HAVE SIGNIFICANT SEIZURES, PREDOMINANTLY ON AWAKENING AROUND 4:00 AM TO 6:00 AM WHEN HE OFTEN HAS CLUSTERS THAT REQUIRE SOME BENZODIAZEPINES FOR CESSATION. THE PHYSICIAN WAS GOING TO INCREASE THE PATIENT¿S ZONEGRAN AND GIVE HIM A DOSE OF DIAZEPAM IN THE MORNING. THE VNS WAS NOT ADJUSTED. THE PHYSICIAN STATED THAT AS THE PATIENT¿S SEIZURES GET MORE FREQUENT, HIS SPONTANEITY INCREASES A BIT MORE AND HE IS A BET LESS LETHARGIC. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH SHOWED 0.43 YEARS REMAINING UNTIL ERI=YES. THE PATIENT UNDERWENT PROPHYLACTIC GENERATOR REPLACEMENT ON (B)(6) 2013. THE EXPLANTED GENERATOR HAS NOT BEEN RETURNED TO THE MANUFACTURER TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272815 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 2258

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention