MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. VARISTEM III; STIMULATOR, NERVE

Catalog Number 8562010

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/21/2019

Event Type  malfunction  

Event Description

The varistim iii nerve locator was turned on, but it did not appear to be functioning correctly.Unable to get device to successfully stimulate.Surgeon and surgery technician attempted to troubleshoot the device, but they were unable to return the vari-stim to an operational status.The varistim was red bagged and removed from service.There was no injury to the patient as a result of the varistim operational failure.The device was picked up by our medtronic representative.

• Brand Name: VARISTEM III
• Type of Device: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint dr. north; jacksonville FL 32216
• MDR Report Key: 9213525
• MDR Text Key: 163020557
• Report Number: 9213525
• Device Sequence Number: 1
• Product Code: GZJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/01/2019,09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8562010
• Device Lot Number: 0216592661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5840 DA