BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3190795 · Received June 26, 2013

    Report

    Report Number
    1644487-2013-01930
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    January 1, 2009
    Report Date
    June 3, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A PATIENT HAD THE VNS DEVICE EXPLANTED ¿A FEW YEARS AGO¿ DUE TO PAIN IN THE EAR, ¿SNOOZING NOISE¿ IN THE EAR, AND LACK OF EFFICACY. THE VNS WAS DISABLED PRIOR TO THE EXPLANT. THE EVENTS OF EAR PAIN AND SNOOZING NOISE (TINNITUS) WERE FELT TO BE DUE TO THE VNS, BUT DID NOT OCCUR DURING STIMULATION PER THE PHYSICIAN. HOWEVER, THE PAIN DID CEASE WHEN THE VNS WAS DISABLED. EVALUATION BY AN ENT PHYSICIAN REVEALED THE TINNITUS WAS NOT FELT TO BE RELATED TO THE VNS. ADDITIONALLY, THE PATIENT REPORTED A LACK OF EFFICACY BUT LATER NOTICED HER POST-ICTAL PHASE WAS BETTER DURING THE VNS THERAPY, SHORTER AND WITH LESS MEMORY LOSS. THE EXPLANT DATE PROVIDED FOR THE GENERATOR IS APPROXIMATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291604 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 200629

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other