FDA Adverse Event Malfunction Summary report: N

NIM® 3.0 INTERFACE

MDR report key: 25120157 · Received May 8, 2026

Report

Report Number: 1045254-2026-00649
Event Type: Malfunction
Date Received: May 8, 2026
Date of Event: April 21, 2026
Report Date: May 8, 2026
Manufacturer: MEDTRONIC XOMED INC.
Product Code: ETN
UDI-DI: 00643169283275
PMA / PMN Number: K083124
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

H3: ANALYSIS DID NOT FIND ANY FAULT WITH THE DEVICE CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID 8253001 - MAINFRAME 8253001 NIM RESPONSE 3.0 IMDRF ANNEX CODES B17, C20 ARE APPLICABLE FOR THIS DEVICE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem · 0

IT WAS REPORTED THAT DURING PRE-OP, THE NIM 3.0 HAD NO STIM RESPONSE. THERE WAS RETURN CURRENT. ISSUE NOT RESOLVED BY REPOSITIONING OR TROUBLESHOOTING. THERE WAS NO PATIENT INVOLVEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
221878	NIM® 3.0 INTERFACE	STIMULATOR, NERVE	ETN	MEDTRONIC XOMED INC.	8253200		00643169283275

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown		"SEE H11...."