MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM® EMG ELECTRODE; ELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH

Model Number	8227410
Medical Device Problem Code	Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	Lead(s), Burn(s) From (3161)
Date of Event	09/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product evaluation: the electrodes were received for analysis.There was no damage or anomalies in the construction of the electrodes that would result in the reported event.The end to end resistance for each side of the paired electrodes shall be <(><<)>2.0 ohms and infinite ohms between needle tips [no short circuit].The actual measurements of the red paired were as follows - one pole measured 1.7 ohms and the other 1.8 ohms with no short circuit between poles (in specification).The actual measurement of the blue paired were as follows - both poles measured 1.7 ohms with no short circuit between poles (in specification).The red/white and green end to end ohms resistance shall be less than 2.5 ohms; the actual measurements for the red/white was 0.9 ohms; the actual measurements for the green was 0.9 ohms (both were in specification).The information most likely indicates a failure to adhere to the ifu warnings.** the instructions for use warns: to avoid alternate site patient burns or lesions: ¿ a.Do not activate the electrosurgical instruments (esu) while stimulator is in contact with tissue.¿ b.Do not leave stimulating electrodes or probes in surgical field.¿ c.Do not store stimulating electrodes or probes in electrosurgical instrument holder.¿ d.Do not allow a second surgeon (for example, fat harvesting) to use electrosurgical instruments while stimulator is in use.¿ e.Do not activate electrosurgical instrument for prolonged periods while esu is not in contact with tissue.¿ f.Do not activate electrosurgical instrument near the recording or stimulating electrodes.¿ g.Do not allow patient interface boxes or recording / stimulating electrodes sites to be flooded with saline.¿ h.Do not allow excessive stray ac or dc leakage currents from patient connected equipment; avoid creating an unintended grounding path through applied electrodes.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
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.

• Brand Name: NIM® EMG ELECTRODE
• Common Device Name: ELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• MDR Report Key: 6942079
• Report Number: 1045254-2017-00360
• Device Sequence Number: 13650080
• Product Code: IKT
• UDI-Device Identifier: 00643169290006
• UDI-Public: 00643169290006
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K002992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/02/2020
• Device Model Number: 8227410
• Device Catalogue Number: 8227410
• Device Lot Number: 0212244318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR