BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMULATOR 8562010 VARI-STIM III 10PK

    MDR report key: 3802380 · Received May 9, 2014

    Report

    Report Number
    1045254-2014-00104
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. THE DEVICE HAS BEEN RETURNED; DEVICE EVALUATION IS UNDERWAY. METHOD - NO TESTING METHODS PERFORMED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE QUALITY ENGINEERING TEAM. RECEIVED ONE (1) SAMPLE WITH ORIGINAL PRODUCT POUCH AND LABEL IDENTIFYING PRODUCT AS PART NUMBER 8562010 VARI-STIM III LOCATOR FROM LOT# 0207838693. ALTHOUGH THERE WAS NO OBVIOUS PRESENCE OF BIO-RESIDUE ON THE PRODUCT, THE PRODUCT WAS FOUND OUTSIDE ITS PACKAGING AND WAS LIKELY USED/HANDLED BY THE CUSTOMER. EQUIPMENT USED: FLUKE MULTIMETER, ASSET# 1153-J, CALIBRATION DUE: JULY 2014. OBSERVATIONS: PER INSTRUCTIONS FOR USE 68E3926 REVISION B THE DEVICE WAS TESTED IN AN "AS RECEIVED CONDITION [0.5MA POSITION]" WITHOUT MOVING THE SWITCH, AND THE DEVICE WOULD LIGHT INDICATING CURRENT DELIVERY WHICH IS NOT CONSISTENT WITH THE REPORTED MALFUNCTION FOR DEVICE NOT WORKING. THE DEVICE WAS THEN FUNCTIONALLY TESTED IN ALL 3 POSITIONS PER INSTRUCTIONS FOR USE AND THERE WAS NO INTERMITTENT BEHAVIOR WHILE MANIPULATING THE SWITCH AND TIP WITHIN THE POSITIONS. THE DEVICE WAS ELECTRICALLY TESTED PER PRODUCT SPECIFICATIONS WITH NO OUT OF SPECIFICATION CONDITION IDENTIFIED. THERE WAS NO EVIDENCE OF IMPROPER MANUFACTURING AND NO FAULT WAS FOUND AS IT RELATES TO THE COMPLAINT THEREFORE MANUFACTURING HAS BEEN RULED OUT AS A POTENTIAL CAUSE. IN CONCLUSION, THE REPORTED COMPLAINT ¿DOES NOT WORK¿ COULD NOT BE DUPLICATED. METHOD ¿ ACTUAL DEVICE EVALUATED; ELECTRICAL EVALUATION; MECHANICAL EVALUATION; VISUAL INSPECTION. RESULTS ¿ NO FAILURE DETECTED. CONCLUSION ¿ NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION.

    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 "THE PRODUCT DOESN¿T WORK." THERE WAS NO REPORT OF PATIENT IMPACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281910 STIMULATOR 8562010 VARI-STIM III 10PK STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8562010 0207838693

    Patients

    Seq Age Sex Outcome Treatment
    1