FREMAP Electrode DCNE-01-05XRecalls & reported problems
Ad-Tech Medical Instrument Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841823108487), received between Jan 29, 2020 and Apr 28, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contaminated at the User Facility” (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 18, 2026.
Most reported problems
Device problems
- Device Contaminated at the User Facility1
- Loss of or Failure to Bond1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2022Device Contaminated at the User Facility; Device Contaminated at the User Facility
DURING ROUTINE INCOMING INSPECTION THE DISTRIBUTOR NOTED A FORIEGN MATERIAL IN THE STERILE PRODUCT POUCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14246033 ↗MalfunctionJan 29, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
ON DECEMBER 14, 2018, AD-TECH RECEIVED A CUSTOMER COMPLAINT INDICATING THAT BEFORE IMPLANTATION IT WAS NOTICED THAT A PLATINUM DISK WAS COMING LOOSE FROM THE SILICONE HOUSING OF AN ELECTRODE. THE ELECTRODE WAS NOT PLACED AND THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9644402 ↗
Other STIMULATOR, NERVE devices
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- 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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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