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

Model Number 8227410

Device Problem Device Stops Intermittently (1599)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2016

Event Type  malfunction  

Manufacturer Narrative

The product analysis indicates that part number 8227410 (paired electrodes) from lot number 0211358568 were received.The paired electrodes were opened and removed from their pouch.The ground and stimulation return electrodes were still in the sealed pouch and therefore not tested.A microscope and multimeter were used for testing.When compared to the assembly drawing, visually there was no external damage to the electrodes which would have resulted in the reported event, which likely rules out mishandling.When compared to the assembly drawing for paired subdermal electrodes, 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 - both poles measured 1.5 ohms with no short circuit between poles (in specification).The actual measurements of the blue paired were as follows - both poles measured 1.6 ohms however measuring from needle to needle showed 0.4 ohms which indicates a short circuit between poles (out of specification) and is likely to have resulted in the intermittent behavior that the customer experienced.

Event Description

During surgery preparation the electrodes cannot steadily (consistently) detect muscles' response.When connected, this pair of electrodes intermittently lost response.The surgeon replaced this pair of electrodes with a new pair and this solved the problem.The event caused an approximately 15-minutes delay and did not cause any harm to the patient.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: NIM® EMG ELECTRODE
• Type of Device: ELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 5906891
• MDR Text Key: 54030544
• Report Number: 1045254-2016-00272
• Device Sequence Number: 1
• Product Code: IKT
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K002992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 8227410
• Device Catalogue Number: 8227410
• Device Lot Number: 0211358568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2016
• Initial Date FDA Received: 08/26/2016
• Supplement Dates Manufacturer Received: 08/01/2016
• Supplement Dates FDA Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR