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	06/06/2018
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
It was reported that the device worked once on the patient, then had to open another one because it didn't work the second time.There was no patient harm.

• 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: 8508932
• Report Number: 1045254-2019-00183
• Device Sequence Number: 11076007
• Product Code: ETN
• UDI-Device Identifier: 00643169341814
• UDI-Public: 00643169341814
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K905035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2019

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: 03/16/2020
• Device Model Number: 8562010
• Device Catalogue Number: 8562010
• Device Lot Number: 0215099701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1