FDA.reportPublic FDA data

MAUDE MDR 4521139

MDR report key
4521139
Report number
1045254-2015-00050
Event key
0
Event type
3
Date of event
2015-01-23
Date received
2015-02-17
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
URIZA SHUMS
Address
6743 SOUTHPOINT DR 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 RESPONSE? 2.0 INTERFACEELECTROMYOGRAPH, DIAGNOSTICMEDTRONIC XOMED, INC.IKN82522008252200NIY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-02-170

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT DURING A MASTOIDECTOMY, THE SYSTEM RECOGNIZED THE ELECTRODES GOING FROM SET-UP TO THE MONITORING SCREEN AND THE CONNECTION WAS "NORMAL". HOWEVER, THERE WAS NO RESPONSE FROM THE ELECTRODE. FOLLOW-UP ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION WITH NO RESPONSE RECEIVED. THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT.

N

Patient 1

(B)(4). A SIMULATOR, PROBE, AND MAINFRAME WERE PROVIDED BY S&R FOR TESTING PURPOSES. THE INTERFACE, SIMULATOR AND PROBE WERE CONNECTED AND THE MAINFRAME TURNED ON; BOOT-UP SEQUENCE COMPLETED WITH NO ERRORS. TOUCHSCREEN RESPONDED. A MONITORING MODE WAS SELECTED USING ALL AVAILABLE CHANNELS. EACH CHANNEL WAS STIMULATED IN TURN; NO RESPONSE WAS SEEN ON ANY CHANNEL. THE COMPLAINT WAS CONFIRMED. THE FUSE WAS REPLACED IN THE PATIENT INTERFACE AND EACH CHANNEL WAS AGAIN STIMULATED. THIS TIME NORMAL AND APPROPRIATE RESPONSES WERE SEEN ON ALL CHANNELS. THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS MISUSE WHERE THE USER CONTACTED THE STIMULATING PROBE WITH ANOTHER HIGH CURRENT DEVICE SUCH AS AN ELECTRO-CAUTERY UNIT. THIS WILL CAUSE A FUSE IN THE PATIENT INTERFACE TO BLOW. (B)(4)

N

Patient 1

FOLLOW-UP FROM THE CUSTOMER INDICATES THEY EXPERIENCED THE SAME CONNECTION ISSUE WITH ALL CHANNELS OF THE PATIENT INTERFACE. WHEN THE PROBE WAS USED, NO WAVEFORM WAS DISPLAYED. THE CASE WAS COMPLETED WITHOUT THE DEVICE. THE EVENT RESULTED IN A 30 MINUTE DELAY. (B)(4).

D

Patient 1

FOLLOW-UP FROM THE CUSTOMER INDICATES THEY EXPERIENCED THE SAME CONNECTION ISSUE WITH ALL CHANNELS OF THE PATIENT INTERFACE. WHEN THE PROBE WAS USED, NO WAVEFORM WAS DISPLAYED. THE CASE WAS COMPLETED WITHOUT THE DEVICE. THE EVENT RESULTED IN A 30 MINUTE DELAY.