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

Model Number	8562010
Medical Device Problem Codes	Use of Device Problem (1670); Device Sensing Problem (2917)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2018
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
A health care provider (hcp) reported that one of the item in the stimulator pack of 10 was not working.They were performing a nerve repair on the hand.During the procedure, the stimulator was opened, pressed black button and nothing happened.They tried to touch ends together and still nothing happened.They tried to touch nerve of the patient and still nothing happened.There was no visual/audible indicators as well as no indicator whether the connection was intermittent.The stimulator was used for the first time.They read the instructions/directions in the package; however, it did not really explain what to do.They opened another package and still it did not work.The case was continued; however, they were unable to use the stimulator to check nerve on the patient.There was no known patient impact reported.
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On follow-up, it was reported that 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: 8065717
• Report Number: 1045254-2018-00591
• Device Sequence Number: 2463024
• Product Code: ETN
• UDI-Device Identifier: 20643169341818
• UDI-Public: 20643169341818
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2018

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: 11/17/2018
• Device Model Number: 8562010
• Device Catalogue Number: 8562010
• Device Lot Number: 0212330206
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1