MAUDE Adverse Event Report: NATUS NEUROLOGY, INCORPORTAED NATUS DISPOSABLE DISC ELECTRODES; ELECTROMYGRAPH

Model Number 019-409000

Device Problem Device-Device Incompatibility (2919)

Patient Problems Injury (2348); Burn, Thermal (2530)

Event Date 06/30/2015

Event Type  Injury  

Manufacturer Narrative

Registered internally as a complaint ((b)(4)) for further investigation by manufacturer.Complainant did not supply specific details regarding all of patient attributes.The electrodes described are manufactured for natus neurology inc.By a contract manufacturer.The electrodes are supplied to natus by a contract manufacturer.The contract manufacturer reviewed the manufacturing and test records for the lot of electrodes identified and found the manufacturing parameters were all within specification.A separate mdr has been created and submitted for the equipment used, viking select emg system p/n 982a0365, (b)(4), (ref mdr 3010611950-2015-00014).Electro-cautery equipment was in use by the complainant at the same time as the natus device in question.There are known risks associated with such device to device combinations where electrodes can intercept stray radio frequency energy and result in thermal heating.Natus safety information supplied to end users states such interactions exist and warns end users that electrode disconnection may be needed to avoid such interactions (ref natus safety reference guide, label #269-594705).

Event Description

During a posterior lumbar interbody fusion procedure using natus disposable electrodes pn 019-409000, the customer has reported burns to the patient at the electrode site while performing emg stimulation and monitoring.The burns occurred when using monopolar electrocautery equipment (not a natus device) for the surgical incisions during the procedure.

• Brand Name: NATUS DISPOSABLE DISC ELECTRODES
• Type of Device: ELECTROMYGRAPH
• Manufacturer (Section D): NATUS NEUROLOGY, INCORPORTAED; 3150 pleasant view road; middleton WI 53562
• Manufacturer (Section G): NATUS NEUROLOGY INCORPORATED; 3150 pleasant view road; middleton WI 53562
• Manufacturer Contact: randall moog ; 3150 pleasant view road; middleton, WI 53562 ; 6088298802
• MDR Report Key: 4996034
• MDR Text Key: 22732023
• Report Number: 3010611950-2015-00009
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K850108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2016
• Device Model Number: 019-409000
• Device Catalogue Number: 019-409000
• Device Lot Number: 505800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2015
• 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 Outcome(s): Other