BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE NERVE STIMULATOR - VARI-STIM® III HAND-HELD

    MDR report key: 4760262 · Received May 8, 2015

    Report

    Report Number
    1045254-2015-00156
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Report Date
    April 14, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K905035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(6). (B)(4). THE DEVICES WERE NOT RETURNED FOR EVALUATION. CONCOMITANT MEDICAL PRODUCTS: VARI-STIM III: ID#8562010, LOT#0208723748, MFR DATE: 09/2014. VARI-STIM III: ID#8562010, LOT#0208476277, MFR DATE: 06/2014. VARI-STIM III: ID#8562010, LOT#0207686450, MFR DATE: 11/2013. VARI-STIM III: ID#8562010, LOT#0207007937, MFR DATE: 05/2013.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 5 VARI-STIM DEVICES WENT BAD DURING A CASE. THERE WAS NO REPORT OF PATIENT INJURY. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION WERE MADE BUT NO INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303464 DISPOSABLE NERVE STIMULATOR - VARI-STIM® III HAND-HELD STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8562010 0208007380

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR