BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM RESPONSE® STIMULATOR PROBE

    MDR report key: 4123319 · Received September 26, 2014

    Report

    Report Number
    1045254-2014-00234
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 27, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K934426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCTS: ID#8229706 NIM TRIVANTAGE 6MM EMG TUBE, LOT/SERIAL NUMBERS UNKNOWN. (B)(4). THE DEVICE WAS RECEIVED. PRODUCT ANALYSIS IS CURRENTLY UNDERWAY.

    Additional Manufacturer Narrative · 1

    BOTH DEVICES WERE EVALUATED BY THE QUALITY ENGINEERING TEAM. DEVICE 1: AS RECEIVED CONDITION: RECEIVED 1 SAMPLE(S), PART NUMBER 8225101. THERE WAS NO OBVIOUS EVIDENCE OF BIOLOGICAL CONTAMINANTS PRESENT ON THE SAMPLE WHEN VIEWED THROUGH UNAIDED EYE. ANALYSIS RESULTS: EQUIPMENT USED: MICROSCOPE (ZEISS STEMI 2000C BETWEEN 0,65 TO 5,0 MAGNIFICATION SETTINGS), FLUKE 21 MULTIMETER, ASSET #1153-J. OBSERVATIONS: AS PER MANUFACTURING DRAWING 65G1086-1 REV. E ITEM# 4 IT IS INDICATED THAT THE PROBE SHALL EXHIBIT CONTINUITY WITH AN END TO END RESISTANCE OF LESS THAN 2 OHMS. RESISTANCE READINGS WERE TAKEN WITH A FLUKE 21 MULTIMETER AND THE READINGS WERE FOUND TO BE LESS THAN 2 OHMS MEETING THE REQUIRED MANUFACTURING SPECIFICATION. BASED ON THE ANALYSIS, THE COMPLAINT EVENT COULD NOT BE DUPLICATED AND THE COMPLAINT IS UNCONFIRMED. THERE WAS NO EVIDENCE OF IMPROPER MANUFACTURING ON THE PROBE COMPONENT ITSELF. CONCLUSION: BASED ON THE ABOVE OBSERVATIONS THE ALLEGED MALFUNCTION ¿NO RESPONSE¿ IS INCONCLUSIVE THAT THE FAILURE COULD NOT BE CONFIRMED. DEVICE 2: AS RECEIVED CONDITION: RECEIVED 1 SAMPLE(S), PART NUMBER 8229706. THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS [BASED OFF OF THE REACTIVITY WITH HYDROGEN PEROXIDE]. ANALYSIS RESULTS: EQUIPMENT USED: MICROSCOPE (ZEISS STEMI 2000C BETWEEN 0,65 TO 5,0 MAGNIFICATION SETTINGS), MULTIMETER. OBSERVATIONS: WHEN COMPARED TO THE ASSEMBLY DRAWING 90A1966 REVISION L, 90A2061 REVISION A, HARNESS 90A1993 REVISION E: THE RESISTANCE OF THE ELECTRODES FROM END TO END SHALL BE LESS THAN 200 OHMS AND THE ACTUAL MEASUREMENT OF EACH CIRCUIT ARE AS FOLLOWS; RED [W/WHITE BAND] 13 OHMS, RED 6 OHMS, BLUE [W/WHITE BAND] 9 OHMS, AND BLUE 10 OHMS. THE INFORMATION INDICATES THERE WERE NO OPEN CIRCUITS AND NO OUT OF SPECIFICATION CONDITION. THERE WAS NO SHORT BETWEEN CIRCUITS AND NO INTERMITTENT BEHAVIOR WHILE MANIPULATING THE TUBE AND WIRES. WHEN VIEWED UNDER MAGNIFICATION, THERE WERE NO CRACKS IN THE ELECTRODE CONTACTS OR DAMAGE TO THE WIRES AND CONNECTORS. THERE WAS NO EVIDENCE OF IMPROPER MANUFACTURING, THERE WERE NO ANOMALIES IN THE CONSTRUCTION WHICH WOULD HAVE RESULTED IN THE REPORTED MALFUNCTION, AND NO FAULT WAS FOUND THEREFORE MANUFACTURING HAS BEEN RULED OUT AS A POTENTIAL CAUSE. CONCLUSION: BASED ON THE ABOVE OBSERVATIONS THE ALLEGED MALFUNCTION ¿NO RESPONSE¿ IS INCONCLUSIVE THAT THE FAILURE COULD NOT BE CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ¿¿ DURING THE IMPLANTATION OF A VAGUS NERVE STIMULATOR. WHEN STIMULATION WAS APPLIED BY THE PRASS MONOPOLAR PROBE, NIM DID NOT RESPOND THOUGH A NERVE WAS OBVIOUSLY STIMULATED. ALSO, IT WAS CERTAIN THAT THE EFFECT OF A MUSCLE RELAXANT WAS NOT PRESENT AND THAT THE PROBE STIMULATED THE VAGUS NERVE (BECAUSE NIM RESPONDED NORMALLY WHEN THE IMPLANTABLE VAGUS NERVE STIMULATOR WAS USED). AFTER ALL, THE DOCTOR GAVE UP ON USING THE PROBE, BUT THE SURGERY WAS COMPLETED WITHOUT DELAY, WITH NO ADVERSE EFFECT TO THE PATIENT. NIM WORKED WELL WITH NO ISSUES WHEN ITS BEHAVIOR WAS INSPECTED USING A SIMULATOR.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602856 NIM RESPONSE® STIMULATOR PROBE STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8225101 NI

    Patients

    Seq Age Sex Outcome Treatment
    1