BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 INTERFACE

    MDR report key: 5890904 · Received August 19, 2016

    Report

    Report Number
    1045254-2016-00267
    Event Type
    Malfunction
    Date Received
    August 19, 2016
    Date of Event
    July 22, 2016
    Report Date
    July 26, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED A NIM MAINFRAME THAT WAS USED IN THE EVENT WAS RETURNED; IT WAS REPORTED THAT THE NIM MAINFRAME DID NOT PASS THE SELF TEST. CONCOMITANT MEDICAL PRODUCTS: 8253002: NIM RESPONSE 3.0 MAINFRAME, SERIAL # (B)(4), LOT # 206033989, MANUFACTURED DATE -JUL/20/2012, 510(K) # K083124. THE NIM PATIENT INTERFACE (PRODUCT #: 8253200) AND THE NIM MAINFRAME (PRODUCT #: 8253002) WERE RETURNED FOR EVALUATION. EVALUATION OF PATIENT INTERFACE (PRODUCT #: 8253200) COULD NOT DUPLICATE CUSTOMER'S COMPLAINT OF NO NERVE REACTION. THERE WAS NO FAULT FOUND WITH THE DEVICE. EVALUATION OF THE NIM MAINFRAME (PRODUCT #: 8253002) CONFIRMED THE CUSTOMER¿S COMPLAINT: ¿DID NOT PASS THE SELF-TEST.¿ ANALYSIS FOUND THAT THE DEVICE WOULD NOT BOOT UP AND THE DSP BOARD FAILED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PATIENT INTERFACE (PRODUCT #: (B)(4) HAS BEEN UPDATED. THERE IS WAVE AND TONE ON THE DEVICE WHEN STIMULATED BUT THE DEVICE IS NOISY. THERE IS NO FAULT WITH THE DEVICE AS IT RELATES TO COMPLAINT HOWEVER THE DEVICE WAS NOISY. A/I PCB ON THE DEVICE WAS LOOSE. THE DEVICE WAS REPAIRED, TESTED TO ALL MANUFACTURING PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: UDI NUMBER FOR NIM MAINFRAME 3.0 ¿ (B)(4). DATE MFR. REC: FEB 20, 2017. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED A NIM MAINFRAME THAT WAS USED IN THE EVENT WAS RETURNED; IT WAS REPORTED THAT THE NIM MAINFRAME DID NOT PASS THE SELF TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO NERVE REACTION BEFORE THE SURGERY. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541178 NIM® 3.0 INTERFACE STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253200 205986863

    Patients

    Seq Age Sex Outcome Treatment
    1