BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2211887 · Received August 10, 2011

    Report

    Report Number
    1644487-2011-01835
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT NEVER FOLLOWED UP WITH THE NEUROSURGEON'S OFFICE TO HAVE HIS DEVICE EVALUATED AND HAS NOT BEEN SEEN BY THE NEUROSURGEON SINCE (B)(6) 2010. FOLLOW UP WITH THE NEUROLOGIST WAS ATTEMPTED AND IT WAS INDICATED THAT THE NEUROLOGIST DID NOT FEEL THAT THE BRADYCARDIA WAS RELATED TO VNS; HOWEVER HE HAD NO OTHER INFORMATION ON THE PATIENT'S CONDITION. HE ALSO INDICATED THAT DIAGNOSTICS WERE NOT PERFORMED ON THE PATIENT'S DEVICE IN OVER A YEAR. NO OTHER INFORMATION WAS PROVIDED. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NEUROSURGEON THAT A VNS PT WANTED HIS DEVICE CHECKED SINCE HE WAS NOT SURE IF IT WAS FUNCTIONING CORRECTLY. ALSO, THE PT WAS GETTING A PACEMAKER IMPLANT DUE TO BRADYCARDIA AND WANTED THE SURGEON TO EVALUATE/MOVE THE DEVICE TO ACCOMMODATE FOR THE PACEMAKER. PT HAS BEEN HOSPITALIZED SEVERAL TIMES OVER THE LAST FEW MONTHS DUE TO CARDIAC ISSUES PER CARDIOLOGIST. THE PT'S CARDIOLOGIST STATED THAT HE WAS NOT SURE IF PT'S BRADYCARDIA WAS RELATED TO VNS OR TO MEDICATION RESPONSE HE RECEIVED DURING INTUBATION. PT WILL LIKELY HAVE A PACEMAKER IMPLANT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A NURSE WITH THE PATIENT'S TREATING CARDIOLOGIST. IT WAS INDICATED THAT THE PATIENT WAS NEVER IMPLANTED WITH A PACEMAKER, AND AFTER EVALUATION, DID NOT REQUIRE ONE. THE NURSE WAS UNABLE TO SAY WHY THEY WERE INITIALLY CONSIDERING IMPLANTING THE PATIENT WITH A PACEMAKER, HOWEVER SHE INDICATED THAT THE PATIENT RECENTLY UNDERWENT A CARDIAC STRESS TEST THAT CAME BACK WITH NORMAL RESULTS. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 200670

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention