FDA.reportPublic FDA data

MAUDE MDR 6034626

MDR report key
6034626
Report number
1045254-2016-00343
Event key
0
Event type
3
Date of event
2016-09-20
Date received
2016-10-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MICHELLE ALFORD
Address
6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US
Phone
904-904-9043
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NIM? EMG ELECTRODEELECTRODE, NEEDLEMEDTRONIC XOMED INC.GXZ82274108227410* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-10-170

Event Narratives#

N

Patient 1

CONCOMITANT MEDICAL PRODUCTS: 8253001: MAINFRAME 8253001 NIM RESPONSE 3.0, S/N (B)(4), LOT 207333371 MANUFACTURED: 08-22-2013; 8253200: PATIENT INTERFACE 8253200 RESPONSE 3.0, S/N (B)(4), LOT 207304806 MANUFACTURED: 08-19-2013; 8225101: PROBE 8225101 5PK STD PRASS FLUSH, LOT UNKNOWN. PRODUCT EVALUATION: ANALYSIS RESULTS NOT AVAILABLE; DEVICE NOT RETURNED, IT WAS DISCARDED AFTER USE. THE INSTRUCTIONS FOR USE PROVIDE THE FOLLOWING: TO AVOID ALTERNATE SITE PATIENT BURNS OR LESIONS: DO NOT ACTIVATE THE ELECTROSURGICAL INSTRUMENTS (ESU) WHILE STIMULATOR IS IN CONTACT WITH TISSUE; DO NOT LEAVE STIMULATING ELECTRODES OR PROBES IN SURGICAL FIELD; DO NOT STORE STIMULATING ELECTRODES OR PROBES IN ELECTROSURGICAL INSTRUMENT HOLDER; DO NOT ALLOW A SECOND SURGEON (FOR EXAMPLE, FAT HARVESTING) TO USE ELECTROSURGICAL INSTRUMENTS WHILE STIMULATOR IS IN USE; DO NOT ACTIVATE ELECTROSURGICAL INSTRUMENT FOR PROLONGED PERIODS WHILE ESU IS NOT IN CONTACT WITH TISSUE; DO NOT ACTIVATE ELECTROSURGICAL INSTRUMENT NEAR THE RECORDING OR STIMULATING ELECTRODES; DO NOT ALLOW PATIENT INTERFACE BOXES OR RECORDING / STIMULATING ELECTRODES SITES TO BE FLOODED WITH SALINE; DO NOT ALLOW EXCESSIVE STRAY AC OR DC LEAKAGE CURRENTS FROM PATIENT CONNECTED EQUIPMENT; AVOID CREATING AN UNINTENDED GROUNDING PATH THROUGH APPLIED ELECTRODES. PRACTITIONER IS RESPONSIBLE FOR PROPER USE, PERIODIC SAFETY CERTIFICATION OF PATIENT CONNECTED EQUIPMENT, AND AC POWER GROUNDING IN ACCORDANCE TO THE APPROPRIATE IEC 60601-1 AND/OR IEC 60601-1-1 MEDICAL SAFETY STANDARD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

IT WAS REPORTED THAT "AFTER THE DRAPES WERE TAKEN OFF THE PATIENT AND THE LEADS FOR THE NIM WERE REMOVED A BURN WAS NOTED ON THE PATIENTS UPPER MID CHEST NEAR HER THROAT WERE A LEAD FOR THE NIM WAS PLACED THAT WAS ROUGHLY A LITTLE LARGER THAN THE SIZE OF A PENCIL ERASER." ADDITIONAL INFORMATION STATES THAT WHEN UNDRAPING THE PATIENT UPON COMPLETION OF THE PROCEDURE, THEY NOTICED THAT THERE WAS A TINY PINPRICK WHERE THE GROUND ELECTRODE HAD BEEN WITH A WHITE CIRCLE SURROUND THE TINY HOLE; PERFECTLY IN THE CENTER. THE WHITE COLOR IS WHAT MADE IT STAND OUT AS A BURN AND NOT A SKIN REACTION TO THE ELECTRODE. BACITRACIN OINTMENT WAS APPLIED TO THE AREA FOR PROTECTION, NO ADDITIONAL INTERVENTIONS WERE PERFORMED. THERE WAS NO SERIOUS INJURY REPORTED.

N

Patient 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.