BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3790742 · Received May 5, 2014

    Report

    Report Number
    1644487-2014-01195
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT WAS EXPERIENCING WORSENING DEPRESSION ABOVE PRE-VNS BASELINE LEVELS. THE PATIENT STATED THAT SHE LOST 5 MONTHS OF LIFE DUE TO VNS AS SHE WOKE UP ONE MORNING AND 5 MONTHS HAD PASSED. THE PATIENT HAD NOT BEEN ADMITTED TO A PSYCHIATRIC WARD SINCE VNS IMPLANT. THE PATIENT WAS ALSO EXPERIENCING A CHARLIE-HORSE TYPE FEELING IN HER NECK/SHOULDER AREA, BUT THE CAUSE WAS UNCLEAR. THE PATIENT¿S DEVICE WAS TESTED DURING AN OFFICE VISIT ON (B)(6) 2014 AND DIAGNOSTIC RESULTS SHOWED NORMAL DEVICE FUNCTION AT THE TIME. THE PATIENT¿S DEVICE SETTINGS WERE INCREASED DURING THE OFFICE VISIT. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION WERE MADE BUT HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266673 PULSE GEN MODEL 102 GENERATOR MUZ CYBERONICS INC 102 14097

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention