MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM® EMG ELECTRODE; ELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH

Model Number	8227411
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One opened sample of part number 8227411, from lot number j314645 was received.There was a residue consistent with biological contaminants on the device.Only the violet electrode was returned.Visually, there was no damage or anomalies in the construction of the device that would have resulted in the reported event.The paired subdermal electrodes shall exhibit continuity from needle tip to connecting pin with a measurement less than 2.0ohms [and shall exhibit infinity between needles and connectors]; the actual measurement was 1.7ohms / 1.7ohms; there was an infinite between poles and no out of specification condition was identified.This is a supplied material assembly with no out of specification condition therefore manufacturing and supplier have been ruled out as likely causes.The instructions for use identifies multiple reasons for a reduced, if not completely eliminate, emg responses to direct or passive neural stimulation [as a result of use error].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.
Event or Problem Description
The facility reported that the when the device was stimulated, there was no sensing.The nerve location was known but the device was not detecting the nerve.The procedure was completed with another set of electrodes.There was no patient impact.

• Brand Name: NIM® EMG ELECTRODE
• Common Device Name: ELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 6835396
• Report Number: 1045254-2017-00299
• Device Sequence Number: 1522147
• Product Code: IKT
• UDI-Device Identifier: 00643169695009
• UDI-Public: 00643169695009
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K002992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/16/2020
• Device Model Number: 8227411
• Device Catalogue Number: 8227411
• Device Lot Number: J314645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2017
• Initial Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1