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	07/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No evaluation has been completed at the time of this report as the device has not been returned.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare professional reported that the varistim did not work.It was the initial use of the device.The user opened another varistim and it worked right away.There was no injury; no patient impact other than a short delay to open another package of varistim.
Additional Manufacturer Narrative
One opened sample of part number 8562010, from lot number 0214664249 was received for analysis.Visually, there was no damage or anomalies in the construction of the device that would have resulted in the reported event.The device was improperly aligned with the 2.0 ma position when received which would not have provide stimulating current.Note ¿ the device has 3 positions and when the marker is aligned to the desired output it clicks in place.The switch was rotated to align with the 2.0 ma position for the analysis and functionally tested per the ifu; 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 0.51ma.¿ position 1.0ma requirement is 1.0ma +/- 0.2ma (0.8ma - 1.2ma), and measures 1.05ma.¿ position 2.0ma requirement is 2.0ma +/- 0.4ma (1.6ma - 2.4ma), and measures 2.08ma.There was no evidence of improper manufacturing and no fault was found as it relates to the complaint; therefore, manufacturing has been ruled out as a likely cause.The ifu indicates: ¿select output amperage by rotating the probe index until marker is aligned with desired output¿; confirm functionality by touching the probe tip and needle electrode; and provides stimulation technique.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: 7812284
• Report Number: 1045254-2018-00385
• Device Sequence Number: 1738900
• Product Code: ETN
• UDI-Device Identifier: 20643169341818
• UDI-Public: 20643169341818
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2018

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: 01/04/2020
• Device Model Number: 8562010
• Device Catalogue Number: 8562010
• Device Lot Number: 0214664249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1