FDA.reportPublic FDA data

MAUDE MDR 9828843

MDR report key
9828843
Report number
9828843
Event key
0
Event type
3
Date of event
2019-08-03
Date received
2020-03-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
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
1NMT NEUROMUSCULAR TRANSTIMULATOR, NERVE, PERIPHERAL, ELECTRICGE HEALTHCAREKOIE-NMT-01* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-130

Event Narratives#

D

Patient 1

DEVICE REQUIRES MANUAL CALIBRATION PRIOR TO INITIATION OF MONITORING. PROVIDERS REPORT MISMATCH BETWEEN BAR GRAPH DEPICTION AND PERCENTAGE DISPLAYED FOR DEGREE OF NEUROMUSCULAR BLOCK. INDEPENDENT VERIFICATION OF DEGREE OF BLOCK USING ALTERNATE TRAIN OF FOUR DEVICES INDICATES NMT MAY BE OVERSENSING MUSCULAR RESPONSE, WHICH LEADS TO OVER-ADMINISTRATION OF PARALYTIC AGENTS DUE TO FALSE INDICATION THAT PATIENT IS INADEQUATELY PARALYZED.