BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INTERFACE 8253200 RESPONSE 3.0

    MDR report key: 2904224 · Received January 9, 2013

    Report

    Report Number
    1045254-2013-00019
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 10, 2012
    Manufacturer
    MEDTRONIC INC
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT PRODUCTS: MAINFRAME 8253001 NIM RESPONSE 3.0; MUTING PROBE 8220325 NIM; PATIENT SIMULATOR 8253600 NIM 3.0 UNIV. (B)(4). THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. IT WAS CONFIRMED THAT THE PATIENT INTERFACE CABLE WILL NOT STIMULATE. THE PC BOARD WAS THEN REPLACED. THE DEVICE WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. CONCOMITANT DEVICES WERE EVALUATED AND THERE WAS NO FAULT FOUND.

    Additional Manufacturer Narrative · 1

    AN EXPIRATION DATE WAS REPORTED ON THE INITAL MDR, HOWEVER THIS DEVICE DOES NOT HAVE AN EXPIRATION DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT STIMULATE. INITIALLY IT WENT COMPLETELY BLACK DURING A CASE. THEY TURNED IT OFF AND BACK ON, BUT THE DEVICE WOULD NOT STIMULATE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12716 PATIENT INTERFACE 8253200 RESPONSE 3.0 STIMULATOR, NERVE ETN MEDTRONIC INC 8253200 205971656

    Patients

    Seq Age Sex Outcome Treatment
    1