BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARI-STIM III

    MDR report key: 1563030 · Received December 15, 2009

    Report

    Report Number
    1563030
    Event Type
    Malfunction
    Date Received
    December 15, 2009
    Date of Event
    December 10, 2009
    Report Date
    December 15, 2009
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    JXE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    FOUR DIFFERENT BATTERY POWERED NERVE STIMULATORS WERE OPENED AND NOT ONE OF THEM WORKED. ALL 4 WERE FROM SEPARATE LOT NUMBERS. ALL 4 WERE FROM SAME MANUFACTURER --MEDTRONIC. ALL APPEARED TO HAVE A DEAD BATTERY. THESE ARE STERILE/DISPOSABLE NERVE STIMULATORS THAT HAVE EITHER AA OR AAA BATTERIES HOUSED IN THE HANDPIECE. WE SUSPECT THAT THEY DID NOT SURVIVE THE ANTICIPATED SHELF LIFE. ONE DUE TO EXPIRE JAN 2011, ONE OF THEM DUE TO EXPIRE JUNE 2011 AND ONE IN AUGUST OF 2011 (ONE OF THEM IS UNKNOWN AS THE WRAPPER WAS NOT SAVED). A 5TH STIMULATOR WAS OPENED AND WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARI-STIM III STIMULATOR, NERVE JXE MEDTRONIC XOMED, INC. 3 DEVICES 8562010 63583700
    2 VARI STIM III NERVE STIMULATOR JXE MEDTRONIC XOMED 8562010 62429300
    3 VARI STIM III NERVE STIMULATOR JXE MEDTRONIC XOMED 8562010 600076700
    4 VARI STIM III NERVE STIMULATOR JXE MEDTROINIC XOMED 8562010 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR