FDA.reportPublic FDA data

MAUDE MDR 4929555

MDR report key
4929555
Report number
3010611950-2015-00003
Event key
0
Event type
3
Date of event
2015-06-30
Date received
2015-07-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
RANDALL MOOG
Address
3150 PLEASANT VIEW ROAD MIDDLETON WI 53562 US
Phone
608-608-6088
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NATUS VIKING SELECTELECTROMYGRAPHNATUS NEUROLOGY, INCORPORTAEDIKN982A0403982A0403Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-07-2101. O

Event Narratives#

D

Patient 1

PATIENT WAS BURNED (ONE BURN ON EACH ANKLE) DURING SPINAL FUSION SURGERY WHERE STIMULATING ELECTRODES WERE ATTACHED TO THE PATIENT. PROCEDURE WAS 6 -- 7 HOURS. CUSTOMER WAS ALSO USING AN ELECTRO-CAUTERY INSTRUMENT (NOT A NATUS PRODUCT) DURING THE SURGERY.

N

Patient 1

1) REGISTERED INTERNALLY AS A COMPLAINT ((B)(4)) FOR FURTHER INVESTIGATION BY MANUFACTURER. 2) THE EQUIPMENT INDICATED WAS RETURNED TO THE MANUFACTURER, TESTED, AND FOUND TO BE OPERATING WITHIN SPECIFICATION. 3) A SEPARATE MDR HAS BEEN CREATED AND SUBMITTED FOR THE ELECTRODES USED (REF MDR 3010611950-2015-00005). 4) 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).