BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 MAINFRAME

    MDR report key: 6428505 · Received March 23, 2017

    Report

    Report Number
    1045254-2017-00090
    Event Type
    Malfunction
    Date Received
    March 23, 2017
    Date of Event
    February 20, 2017
    Report Date
    February 24, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    UDI-DI
    00613994499714
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S): 8220325 - NIM MUTING PROBE; SERIAL NUMBER ¿ UNKNOWN; LOT NUMBER ¿ UNKNOWN; MANUFACTURED DATE ¿ UNKNOWN; UDI NUMBER ¿ (B)(4); 510K NUMBER - K083124. 8253200 ¿ NIM 3.0 PATIENT INTERFACE; SERIAL NUMBER - (B)(4); LOT NUMBER ¿ 206905285; MANUFACTURED DATE ¿ APRIL 16, 2013; UDI NUMBER ¿ (B)(4); 510K NUMBER - K083124. XOM UNK NIM ACC ¿ (UNKNOWN PRODUCT ID, STIMULATING PROBE); LOT NUMBER ¿ UNKNOWN; MANUFACTURED DATE ¿ UNKNOWN; UDI NUMBER ¿ UNKNOWN; 510K NUMBER - UNKNOWN. A 8253001 (NIM RESPONSE 3.0 MAINFRAME): THE PRODUCT ANALYSIS INDICATES THAT THE REPORTED ISSUE COULD NOT BE DUPLICATED. FOUR HOURS OF BURN-IN TESTING WAS PERFORMED. THERE WAS NO FAULT FOUND WITH THE DEVICE. IT WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. A 8220325 (NIM MUTING PROBE): THE PRODUCT ANALYSIS INDICATES THAT THE DEVICE CAME IN WITH BROKEN FERRITE AND CANNOT BE REPAIRED. A 8253200 (NIM 3.0 PATIENT INTERFACE): THE PRODUCT ANALYSIS INDICATES THAT THE REPORTED ISSUE COULD NOT BE DUPLICATED. WAVE WASHERS WERE REPLACED DUE TO A LOOSE CABLE CLIP. THE DEVICE WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. XOM UNK NIM ACC (NIM STIMULATING PROBE): THE DEVICE WAS NOT RETURNED. A PRODUCT ANALYSIS HAS NOT BEEN PERFORMED. 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT, TOTAL THYROID LOBECTOMY WITH ISTHMUSECTOMY, THE DEVICE WAS INTERMITTENTLY STIMULATING. FOLLOW-UP INFORMATION INDICATES THAT A BACK-UP MONITORING SYSTEM WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY OR IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209864 NIM® 3.0 MAINFRAME STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253001 206926138 00613994499714

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR