MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM® PROBE; STIMULATOR, NERVE

Model Number	8225825
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported via a manufacturer representative that the probe was not detecting the contact on the patient during the procedure.The device failed to work as no audible tone was heard during exploration.Troubleshooting was done by using another device and proceeding with the case.There was no delay in the procedure.There was no patient impact.
Additional Manufacturer Narrative
Analysis found that the tip securely attached to the handle.There was no visible damage to the exterior of the device note ¿ for clarity, the molex connector will be designated as connection 1, the wire next to the molex 2, the wire next to the protected pin connector 3, and the protected pin connector 4.The drawing requires a connection resistance of 5 ohms; the actual measurement between 1 and 4 was ¿o.L.¿, or open circuit.There was no intermittent behavior while manipulating the strain relief during the electrical test.The handle of the probe was split open for additional analysis.The resistance between 1 and 4 was checked again, and it was still an open circuit.The insulation was pulled back to expose connections 2 and 3.There was continuity between 2 and 3, 1 and 2, 1 and 3, however there was no continuity between 3 and 4.The information indicates that there is an issue with the electrical connection inside the protected pin connector or its strain relief.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NIM® PROBE
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7903362
• Report Number: 1045254-2018-00455
• Device Sequence Number: 169155
• Product Code: ETN
• UDI-Device Identifier: 00885074472911
• UDI-Public: 00885074472911
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K934426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2019

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: 06/03/2021
• Device Model Number: 8225825
• Device Catalogue Number: 8225825
• Device Lot Number: 0215589576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 04/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1