BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3192903 · Received June 27, 2013

    Report

    Report Number
    1644487-2013-01948
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    January 1, 2013
    Report Date
    May 28, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE NURSE PRACTITIONER CALLED AND REPORTED THAT THE PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES. HE STATED THAT HE WAS CONCERNED THAT THE DEVICE MAY BE NEARING END OF SERVICE, BECAUSE THE PATIENT WAS PROGRAMMED TO A HIGH OUTPUT CURRENT AND DUTY CYCLE (OUTPUT CURRENT OF 3.25MA, HAS A DUTY CYCLE OF 36% OR 21 SECONDS OF ON TIME AND 0.8 MINUTES OF OFF TIME). THERE HAS NOT BEEN ANY RECENT PATIENT TRAUMA OR PATIENT MANIPULATION OF THE DEVICE. THE NURSE PRACTITIONER WAS UNABLE TO ANSWER IF THERE WERE POSSIBLE CONTRIBUTING FACTORS, BECAUSE HE HAD NOT HAD A CHANCE TO LOOK THROUGH THE PATIENT'S CHART. ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION; HOWEVER, THEY WERE UNSUCCESSFUL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT'S VNS GENERATOR WAS PROPHYLACTICALLY REPLACED. PRE-OP INTERROGATION AND DIAGNOSTICS WERE PERFORMED ON THE DEVICE WHICH FOUND THAT SYSTEM DIAGNOSTICS WERE WITHIN NORMAL LIMITS. TWO INTRO-OPERATIVE SYSTEM DIAGNOSTICS WERE PERFORMED ON THE NEWLY IMPLANTED DEVICE, WHICH SHOWED THE NEW DEVICE WAS WITHIN NORMAL LIMITS. THE EXPLANTED DEVICE WAS SENT TO THE HOSPITAL'S PATHOLOGY DEPARTMENT PER HOSPITAL POLICY. ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294822 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 2386

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other