BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAINFRAME 8253002 NIM RESPONSE 3.0 INTL

    MDR report key: 2884096 · Received December 21, 2012

    Report

    Report Number
    1045254-2012-00759
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 22, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE CUSTOMER'S COMPLAINT OF A FALSE NEGATIVE COULD NOT BE DUPLICATED OR CONFIRMED. THE CF CARD WAS REPLACED AND THE SOFTWARE WAS UPGRADED. ADDITIONALLY THERE WAS FAULT FOUND WITH THE PATIENT INTERFACE CABLE. THE COMPONENT WAS REPLACED. THE UNIT WAS TESTED AND PASSED MET MANUFACTURING SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    A NIM RESPONSE 3.0 PATIENT INTERFACE (B)(4) WAS ALSO INVOLVED IN THIS EVENT. HOWEVER, IT WAS REPORTED TO THE FDA ON MDR #104 5254-2012-00750. THE DEVICE ANALYSIS SUBMITTED IN THE INITIAL REGULATORY REPORT WAS FOR THE PATIENT INTERFACE. THE NIM RESPONSE 3.0 MAINFRAME (B)(4) WAS ALSO RETURNED FOR EVALUATION. THERE WAS NO FAULT FOUND WITH THE MAINFRAME AND THE ALLEGED COMPLAINT COULD NOT BE DUPLICATED...IN LIEU OF THIS, ANALYSIS FOR THE PATIENT INTERFACE FOUND FAILURE IN THE CABLE DUE TO A SHORT AND WAS THEREFORE REPLACED. BOTH DEVICES WERE TESTED TO SPECIFICATIONS AND HAVE BEEN RETURNED TO THE CUSTOMER. THE INITIAL REGULATORY REPORT ONLY INDICATED THE RESULT AND CONCLUSION OF THE PATIENT INTERFACE, THEREFORE THE FOLLOWING CODES ARE BEING UPDATED: RESULT: NO FAILURE DETECTED. CONCLUSION: NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC THAT WHEN STIMULATING WITH A PROBE, THE MAINFRAME DOES NOT GIVE ANY SIGNAL. THERE WAS NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAINFRAME 8253002 NIM RESPONSE 3.0 INTL STIMULATOR, NERVE ETN MEDTRONIC, INC. 8253002 73127300

    Patients

    Seq Age Sex Outcome Treatment
    1