FDA.reportPublic FDA data

MAUDE MDR 2578511

MDR report key
2578511
Report number
1028232-2012-01190
Event key
0
Event type
3
Date of event
2012-03-14
Date received
2012-05-11
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 4137PACER LEADBIOTRONIK SE & CO. KGNVZ358764358764R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-05-1101. H

Event Narratives#

D

Patient 1

BOSTON SCIENTIFIC RECEIVED INFO THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLD MEASUREMENTS OF 5 VOLTS AT 1.0 MS. A REVISION PROCEDURE WAS PERFORMED. THE LEAD WAS SURGICALLY CAPPED AND ABANDONED. NO ADD'L ADVERSE PT EFFECTS WERE REPORTED. AS NO FURTHER INFO CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFO BE PROVIDED.

N

Patient 1

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE. THE MFG PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MFG PROCESS, WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.