FDA.reportPublic FDA data

MAUDE MDR 6360793

MDR report key
6360793
Report number
MW5068138
Event key
0
Event type
3
Date of event
2017-02-18
Date received
2017-02-23
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#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COVIDIEN ADAPTERADAPTERCOVIDIENDRWREF 3354133541278428I Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-02-230

Event Narratives#

D

Patient 1

TELEMETRY MONITOR SHOWED VENTRICULAR TACHYCARDIA. WHEN PT WAS ATTACHED TO DEFIBRILLATOR THE RHYTHM SHOWED NORMAL SINUS RHYTHM. TELEMETRY MONITOR CONTINUED TO SHOW VENTRICULAR TACHYCARDIA. TELEMETRY MONITOR, LEADS AND PADS WERE CHANGED AND RHYTHM THEN SHOWED NORMAL SINUS RHYTHM.