FDA.reportPublic FDA data

MAUDE MDR 3688529

MDR report key
3688529
Report number
1045254-2014-00064
Event key
0
Event type
3
Date of event
2014-02-26
Date received
2014-03-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
AMY CORRALES
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
1MAINFRAME 8252001 NIM-RESPONSE 2.0ELECTROMYOGRAPH, DIAGNOSTICMEDTRONIC XOMED, INC.IKN82520018252001N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-03-190

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THEY WERE NOT GETTING A RESPONSE WHEN ATTEMPTING TO STIMULATE THE NERVE WITH THE NIM RESPONSE 2.0. THEY HAD THEIR STIM SET TO 1.0MA AND THRESHOLD AT 100UA. THEY TRIED LOWERING THE THRESHOLD BUT THIS DID NOT RESOLVE THE ISSUE. SURGEON WAS ABORTING USE OF NIM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

N

Patient 1

THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. NO TESTING METHODS PERFORMED.

N

Patient 1

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