BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2458870 · Received February 17, 2012

    Report

    Report Number
    1644487-2012-00431
    Event Type
    Injury
    Date Received
    February 17, 2012
    Date of Event
    January 25, 2012
    Report Date
    January 25, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE EXPLANTED GENERATOR WAS RETURNED FOR PRODUCT ANALYSIS. IN THE PA 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; THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A VNS PATIENT REPORTED THAT THE BATTERY OF HER VNS WAS AT END OF SERVICE. THE PATIENT THEN MADE A STATEMENT THAT IF SHE DIDN'T GET HELP REPLACING HER VNS THEN SHE WAS GOING TO KILL HERSELF. THE PATIENT'S PSYCHIATRIST WAS CONTACTED AND INFORMED OF THIS STATEMENT. THE PSYCHIATRIST'S NURSE WAS UNABLE TO CONFIRM IF THE DEVICE WAS AT END OF SERVICE AND STATED THAT THE PATIENT WAS COMING IN SOON, DATE UNKNOWN, AND THEY WOULD CHECK TO SEE IF IT WAS AT END OF SERVICE. THE NURSE FURTHER STATED THAT WHEN THE PATIENT CAME IN FOR THE FOLLOW-UP SHE WOULD INFORM THE MANUFACTURER IF THE VNS WAS AT END OF SERVICE OR NOT; HOWEVER NO INFORMATION HAS BEEN RECEIVED FROM THE NURSE TO DATE. A BATTERY LIFE CALCULATION WITH THE PROGRAMMING HISTORY AVAILABLE SHOWED 0.52 YEARS UNTIL THE ELECTIVE REPLACEMENT INDICATOR=YES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2013 WHEN A VNS THERAPY ACCESS PROGRAM ORDER FORM FOR THE PATIENT WAS RECEIVED REPORTING THAT THE PATIENT WAS REFERRED FOR SURGERY. THE PATIENT'S GENERATOR WAS REPLACED ON (B)(6) 2013 DUE TO END OF SERVICE. ATTEMPTS FOR THE RETURN OF THE EXPLANTED GENERATOR HAVE BEEN MADE BUT THE DEVICE HAS NOT BEEN RETURNED FOR PRODUCT ANALYSIS TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR MUZ CYBERONICS, INC. 102 013755

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention