MAUDE MDR 3752923

MDR report key
3752923
Report number
3752923
Event key
0
Event type
3
Date of event
2013-12-02
Date received
2014-03-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CASCADE ELITESTIMULATOR, PHOTIC, EVOKED RESPONSECADWELL LABORATORIES, INC.GWE12N/AN/A Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-03-210

Event Narratives#

D

Patient 1

INTRAOPERATIVE MONITORING TECHNICIANS OBSERVED DIFFERENCES IN THE RESPONSES (MORPHOLOGY) OF THE LEFT UPPER EXTREMITY AS COMPARED TO THE RIGHT UPPER EXTREMITY. SPECIFICALLY, THE LEFT UPPER RESPONSE LATENCY WAS 2.5MS EARLIER WITH REDUCED AMPLITUDE AND THE PERIPHERAL (ERB) HAD MINOR PEAK PRECEDING THE ASSUMED ACTUAL RESPONSE. THE TECHNICIANS REMOVED THE ES-IX STIMULATOR FROM USE REPLACING IT WITH THE ES-5-100 STIMULATOR. THE PROGRAM WAS RESET WITH THE SAME STIMULATION PARAMETERS AND MONITORING RESUMED. THE RESPONSES IN QUESTION THEN HAD HIGHER AMPLITUDE, SLOWER RESPONSE LATENCY, AND THE PERIPHERAL (ERB) WAS WITHOUT THE MINOR PEAK. THE RESPONSES NOW CORRELATED WITH THE LEFT SIDE.TECHNICIAN'S FURTHER EXPLANATION: A SIMPLIFIED DESCRIPTION IS THAT THE PATIENT'S "BASELINE" SENSORY AND/OR MOTOR RESPONSES ARE RECORDED JUST PRIOR TO SURGERY. ALL ACQUIRED RESPONSES FROM THAT POINT ON ARE REFERENCED TO THE BASELINE. CHANGES IN THE RESPONSE CAN OCCUR FROM MANY INFLUENCES, ANESTHESIA, TEMPERATURE, THE POSITION OF A LIMB, OR THE ACTUAL SURGICAL PROCEDURE. IF THERE IS ANY CHANGE IN THE RESPONSE THE IOM TECHNICIAN NEEDS TO DETERMINE THE CAUSE. IF THESE INFLUENCES ARE RULED OUT AND CANNOT BE ATTRIBUTED TO CAUSES OTHER THAN THE SURGICAL PROCEDURE THE TECHNICIAN WILL NOTIFY THE SURGEON OF THE CHANGE. THE SURGEON THEN DECIDES HOW TO PROCEED.