FDA.reportPublic FDA data

MAUDE MDR 2063001

MDR report key
2063001
Report number
1028232-2011-00825
Event key
0
Event type
3
Date of event
2011-01-14
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 CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED HIGH THRESHOLD MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE NOTED. THIS LEAD WAS EXPLANTED AND RETURNED. THE DATE OF EXPLANT WAS NOT PROVIDED.