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

Model Number	8562010
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the vari-stim iii did not stimulate when tested, despite the battery indicator light coming on prior to use.The event is not associated with a patient.
Additional Manufacturer Narrative
The product analysis indicates one opened sample, part number 8562010, from lot number 0214125809.There was a residue consistent with biological contaminants on the device.Visually, there was no damage or anomalies in the construction of the device that would have resulted in the reported event.The device was set to the 2.0 ma position when received and was functionally tested per the ifu in the as received condition; the device would light which indicates it was delivering stimulating current and is not consistent with the reported event.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 0.50ma.¿ ¿ 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 2.03ma.¿ there was no evidence of improper manufacturing and no fault was found as it relates to the complaint.¿ complaint substantiated / confirmed: no 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: 7405532
• Report Number: 1045254-2018-00156
• Device Sequence Number: 18853007
• Product Code: ETN
• UDI-Device Identifier: 20643169341818
• UDI-Public: 20643169341818
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K905035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2018

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: 10/02/2019
• Device Model Number: 8562010
• Device Catalogue Number: 8562010
• Device Lot Number: 0214125809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1