N/A 8228053Recalls & reported problems
Medtronic Xomed, Inc. · ELECTRODE 8228053 APS 3MM ROHS · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000034092), received between Jun 23, 2020 and Jun 23, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K083124); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Separation1
- Use of Device Problem1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2020Material Separation; Use of Device Problem; Material Separation; Use of Device Problem
ADDITIONAL INFORMATION RECEIVED STATED THAT THERE WAS NO OTHER INTERVENTION PERFORMED TO LOCATE THE MISSING POINT. THE ELECTRODE WAS UNPACKED NORMALLY AND NOT INSPECTED BEFORE USING IT TO DETERMINE IF THERE WAS DAMAGED. METAL ELECTRODE WAS NOT FOUND AND CUSTOMER DOES NOT KNOW WHERE IT WAS LOST. THERE WAS NO DECLARATION OF PATIENT IMPACT FOR THIS INCIDENT.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 10183475 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K083124. One submission often covers many models, so check the product and lot details in each record.
- Z-2344-2012 · Sep 27, 2010 · TerminatedInterfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pulse). LABELING: Box Label: REF 8253210 x1***NIM-Response 3.0 Patie
- Z-2343-2012 · Sep 27, 2010 · TerminatedInterfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro). LABELING: Box Label: REF 8253410 x1***NIM-Response 3.0 Patie
- Z-2342-2012 · Sep 27, 2010 · TerminatedInterfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response) LABELING: Box Label: REF 8253200 x1***NIM-Response 3.0 Patient
Other STIMULATOR, NERVE devices
- NIM Vital NIM4CM01Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls260 reports
- NIM TriVantage® 8229707Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls176 reports
- NIM® 8229306Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall1 death167 reports
- NIM Vital™ NIM4CPB1Medtronic Xomed, Inc. · STIMULATOR, NERVE3 recalls45 reports
- NIM Trivantage® 8229707Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall142 reports
- NIM® 8229307Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall138 reports
- NIM TriVantage® 8229706Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls78 reports
- NIM-Response® 8253002Medtronic Xomed, Inc. · STIMULATOR, NERVE171 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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