BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2141185 · Received June 22, 2011

    Report

    Report Number
    1644487-2011-01391
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    March 15, 2006
    Report Date
    May 23, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT THAT SHE WAS HAVING A LOT OF GASTRIC REFLUX PROBLEMS AND THOUGHT IT MAY BE DUE TO HER VNS. SHE ALSO REPORTED A PAIN IN BETWEEN HER VAGUS NERVE AND ESOPHAGUS. THE PT DID WANT THE VNS EXPLANTED AS IT HAD NOT BEEN BENEFICIAL FOR HER. THE DEVICE HAD BEEN TURNED OFF DUE TO THE PAIN, BUT THE PAIN WAS STILL PRESENT WHEN SHE EATS. FURTHERMORE, THE PT CLAIMED TO HAVE AN IRREGULAR HEARTBEAT, WHICH SHE DID NOT KNOW IF IT WAS RELATED TO VNS. ALL OF THE PT'S PROBLEMS SUPPOSEDLY BEGAN AFTER SHE WAS IMPLANTED. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 MUZ CYBERONICS, INC. 102 014188

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other