MAUDE Adverse Event Report: MEDTRONIC XOMED INC. DISPOSABLE NERVE STIMULATOR - VARI-STIM® III HAND-HELD; STIMULATOR, NERVE

Model Number	8562010
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2019
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 healthcare professional (hcp) reported that the nerve locator did not work.A second one was opened with a different lot number which worked.There was no patient impact.
Additional Manufacturer Narrative
Product analysis: the device was not aligned with one of the 3 positions when receive.The device was moved to the 2.0ma position and would light when touching the probe tip to the grounding needle per the instructions for use which indicates it was delivering stimulating current.The device was functionally tested in the other two positions with no issues or intermittent behavior while manipulating the switch and tip within the positions.The device was electrically tested per the xpi with no out of specification condition identified: ¿ ¿ position 0.5ma requirement is 0.5ma +/- 0.1ma (0.4ma - 0.6ma), and measures 0.50ma.¿ ¿ position 1.0ma requirement is 1.0ma +/- 0.2ma (0.8ma - 1.2ma), and measures 1.02ma.¿ ¿ position 2.0ma requirement is 2.0ma +/- 0.4ma (1.6ma - 2.4ma), and measures 2.05ma.The information most likely indicates the device was not used in accordance with the ifu.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DISPOSABLE NERVE STIMULATOR - VARI-STIM® III HAND-HELD
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 9145190
• Report Number: 1045254-2019-00484
• Device Sequence Number: 2657073
• Product Code: ETN
• UDI-Device Identifier: 00643169341814
• UDI-Public: 00643169341814
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K905035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

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: 04/22/2020
• Device Model Number: 8562010
• Device Catalogue Number: 8562010
• Device Lot Number: 0215318717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1