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	11/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis found that visually, there was no damage or anomalies in the construction of the device that would have resulted in the reported event.The device was aligned with the 2.0 ma position when receive; the device would light which indicates it was delivering stimulating current.The device was then 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 with no out of specification condition identified:position 0.5ma requirement is 0.5ma +/- 0.1ma (0.4ma - 0.6ma), and measures 0.48ma, position 1.0ma requirement is 1.0ma +/- 0.2ma (0.8ma - 1.2ma), and measures 0.99ma and position 2.0ma requirement is 2.0ma +/- 0.4ma (1.6ma - 2.4ma), and measures 1.97ma.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported that the stim was opened on the sterile field in preparation for use during the procedure, however the device did not work with multiple attempts.There was no visual or audible indicators that alerted the user of the issue.There was a minor delay while opening the unit; however, there was no adverse effect to the patient.The hcp opened another one and continued with the procedure.There was no patient impact.

• 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: 8060654
• Report Number: 1045254-2018-00586
• Device Sequence Number: 2746019
• Product Code: ETN
• UDI-Device Identifier: 20643169341818
• UDI-Public: 20643169341818
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K905035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2018

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: 10/20/2018
• Device Model Number: 8562010
• Device Catalogue Number: 8562010
• Device Lot Number: 0212169563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR