MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION NEXFRAME INSTRUMENT, STEREOTAXIC

Model Number DB-2040

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative regarding an unknown navigation system. It was reported that there was an issue during navigation using the nexframe. The caller reported they were unable to reach the intended target and were off by 1. 6mm or 1. 9mm. The caller at one point mentioned a possible 25 degree off target, or seemed to be more lateral. The issue occurred yesterday, but the caller indicated the patient was implanted and the outcome was good. Additional information was received: it was reported that the cause of the inaccuracy was not identified. It seemed the nexframe would not "reach" them when trying to align to the target. It would not allow the dot to line up in the circle. There was no confirmed shifting or other possible reasons for the inaccuracy. The type of procedure was for a lead placement. Additional troubleshooting was the surgeon attempting to align to the target several times and was 1. 7-2. 0mm off target. They removed the new probe and reattached, but they were unable to get aligned. The product was disposed and would not be returned.

• Brand Name: NEXFRAME
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11734881
• MDR Text Key: 250437684
• Report Number: 2182207-2021-00708
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/27/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: DB-2040
• Device Catalogue Number: DB-2040
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/06/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown