BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2101920 · Received May 18, 2011

    Report

    Report Number
    1644487-2011-01107
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 18, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A VNS PT THAT DURING AN APPOINTMENT WITH HER NEUROLOGIST AN ERROR MESSAGE WAS RECEIVED. SINCE PT WAS RECENTLY IMPLANTED (ON (B)(6) 2011), THE NEUROLOGIST REFERRED THE PT TO THE NEUROSURGEON. THE NEUROSURGEON PERFORMED DIAGNOSTICS AND RECEIVED HIGH IMPEDANCE, DCDC=7. THE PT DID NOT HAVE ANY RECENT FALLS. HER SEIZURE CONTROL WAS GOOD AS SHE HAS NOT HAD A SEIZURE IN 6 MONTHS. X-RAY IMAGES WERE TAKEN; HOWEVER, THE IMAGES WERE NOT SENT TO THE MANUFACTURER. PT ALSO COMPLAINED OF CONTINUOUS PAIN AT THE GENERATOR SITE AS THE GENERATOR WAS NOT TURNED OFF. GOOD FAITH ATTEMPTS TO OBTAIN MORE INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 2889

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female