FDA.reportPublic FDA data

MAUDE MDR 2058982

MDR report key
2058982
Report number
1028232-2011-00792
Event key
0
Event type
3
Date of event
2011-02-11
Date received
2011-04-07
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. KGNVZ358754358754R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-04-0701. H

Event Narratives#

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 MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING 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.

D

Patient 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEXTRUS LEAD WAS EXHIBITING NO CAPTURE DESPITE MAXIMUM DEVICE OUTPUTS AND DIAPHRAGMATIC STIMULATION. THEREFORE, A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REMOVED FROM SERVICE WITHOUT FURTHER INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD WAS NOT RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.