FDA.reportPublic FDA data

MAUDE MDR 2062998

MDR report key
2062998
Report number
1028232-2011-00821
Event key
0
Event type
3
Date of event
2011-02-16
Date received
2011-04-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
6024 JEAN ROAD LAKE OSWEGO OR 97035 US
Phone
877-877-8772
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DEXTRUS 4136PACER LEADBIOTRONIK SE AND CO. KGNVZ358754358754* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-04-1101. H

Event Narratives#

D

Patient 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD DISPLAYED NOISE AND POOR R WAVE MEASUREMENTS IN BOTH CONFIGURATIONS. AT THE LAST FOLLOW-UP VISIT, THE LEAD HAD BEEN PROGRAMMED TO UNIPOLAR CONFIGURATION SINCE THE R WAVE MEASUREMENTS WERE BETTER IN THIS CONFIGURATION. THE NOISE RESULTED IN VENTRICULAR TACHYCARDIA EPISODES AND WAS RECREATED WITH ISOMETRICS IN UNIPOLAR CONFIGURATION. THE NOISE COULD NOT BE RECREATED IN BIPOLAR CONFIGURATION. THE IMPEDANCE MEASUREMENTS CHANGED AFTER IMPLANT BUT HAVE BEEN STABLE OVER THE LAST YEAR, AS HAVE THE THRESHOLD MEASUREMENT. THE LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD.