NVM5 2010014Recalls & reported problems
Nuvasive, Inc. · NVM5 Dual Gel Electrodes, 14 Pack · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517699213), received between Sep 29, 2023 and Sep 29, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Patient-Device Incompatibility1
Patient problems
- Anaphylactic Shock1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL EXTREME LATERAL INTERBODY FUSION PROCEDURE AT L4/5. DURING THE PROCEDURE, AFTER THE DUAL GEL ELECTRODES WERE PLACED ON THE PATIENT, THE PATIENT WENT INTO ANAPHYLACTIC SHOCK. THE PROCEDURE WAS STOPPED AND THE PATIENT'S CONDITION WAS REPORTED TO HAVE SUBSIDED. THE SURGERY WAS ABORTED AND IS PLANNED TO BE RESCHEDULED AFTER TESTING FOR THE CAUSATIVE AGENT OF THE ALLERGY IS CONDUCTED. THE RESULTS OF THE ALLERGY TESTING WERE REQUESTED BUT ARE NOT AVAILABLE AT THIS TIME. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Patient problems: Anaphylactic Shock
MAUDE report 17848433 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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