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NA 8227410Recalls & reported problems

Medtronic Xomed, Inc. · ELECTRODE 8227410 PAIRED 2 CH SET ROHS · Class 2

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 00643169290006), received between Oct 11, 2017 and Dec 6, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Component or Accessory 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Component or Accessory Incompatibility1
  • Noise, Audible1
  • Use of Device Problem1

Patient problems

  • Lead(s), Burn(s) From1
  • 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.

  • MalfunctionDec 6, 2018Use of Device Problem; Noise, Audible; Use of Device Problem; Noise, Audible

    A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE ELECTRODES SEEMED TO BE FAULTY DURING RIGHT PAROTIDECTOMY. THE DOCTOR SAID THE MACHINE WAS BEEPING IRREGULARLY. THE SURGEON DISCONNECTED THE ELECTRODES FROM THE WHITE BOX AND PLUGGED BACK IN. WHEN THAT DID NOT WORK HE REMOVED THE ELECTRODES FROM THE PATIENT AND APPLIED A NEW ONES WHICH WORKED FINE. THERE WAS 5 MINUTES DELAY. THERE WAS NO PATIENT IMPACT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8137033 ↗
  • MalfunctionOct 11, 2017Component or Accessory Incompatibility; Component or Accessory Incompatibility

    THE PHYSICIAN REPORTED THAT WHEN SETTING UP FOR A COCHLEAR IMPLANT THE SKIN WHERE THE NIM ELECTRODES WOULD BE APPLIED WAS DISINFECTED USING THEIR ¿NORMAL PROCEDURE¿. FOLLOWING THE PROCEDURE IT WAS NOTED THAT A ¿BURN WOUND OCCURRED BETWEEN THE GROUND CORD AND STIM RETURN CORD LOCATED: WIDTH - 1 CM AND DEPTH - 0.1 CM - 0.3 CM (ONE SIDE TO THE OTHER SIDE).¿ THE PHYSICIAN REMOVED THE ¿BURN PARTS AND STITCHED THE WOUND.¿ FOLLOWING THE PROCEDURE, THE GROUND CORD AND STIM RETURN CORD WERE TESTED; BOTH ¿ACTED NORMALLY¿. IT WAS CONFIRMED THAT DURING THE PROCEDURE A ¿BI-POLAR CONMED¿ WAS USED AND THE CABLES OF THE ¿BI-POLAR CONMED¿ AND THE ELECTRODES WERE SIDE BY SIDE. AT THIS TIME, THE PATIENT¿S SKIN IS HEALING.

    Patient problems: Lead(s), Burn(s) From

    MAUDE report 6942079 ↗

Other ELECTRODE, NEEDLE devices

All ELECTRODE, NEEDLE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.