BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2871434 · Received December 13, 2012

    Report

    Report Number
    1644487-2012-03321
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    August 29, 2012
    Report Date
    December 3, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ON (B)(6) 2012 IT WAS REPORTED THAT THE VNS PATIENT HAS AN INCREASE IN SEIZURES WHEN THE PATIENT'S MOTHER USES HIS VNS MAGNET ON HIM. IT WAS ALSO REPORTED THAT THE PATIENT HAS VOICE VIBRATIONS DURING STIMULATION. THE PHYSICIAN LATER REPORTED THAT HE WAS NOT AWARE OF THE INCREASE IN SEIZURES WITH MAGNET STIMULATION. THE VOICE VIBRATIONS HAS NOTED TO BEEN SINCE THE VNS WAS IMPLANTED AND OCCURS WITH STIMULATION. THE PATIENT'S STIMULATION WAS REDUCED DUE TO THE VOICE VIBRATIONS. THE PATIENT'S DIAGNOSTICS WERE NOTED TO SHOW A LEAD IMPEDANCE OF "OK". THE PHYSICIAN STATED THAT THE INCREASE IN SEIZURES IS LIKELY UNRELATED TO VNS AND HE HAS NOT TAKEN ANY INTERVENTIONS AS HE IS NOT CONVINCED THAT THE EPISODES ARE RELATED TO VNS. THE INCREASE IN SEIZURES WAS RELATIVELY UNCHANGED COMPARED TO PRE-VNS BASELINE LEVELS. NO CAUSAL OR CONTRIBUTORY PROGRAMMING CHANGES, MEDICATION CHANGES, OR OTHER EXTERNAL FACTORS PRECEDED THE ONSET OF THE INCREASE IN SEIZURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 202009

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR