FDA.reportPublic FDA data

MAUDE MDR 2639653

MDR report key
2639653
Report number
1028232-2012-01681
Event key
0
Event type
3
Date of event
2012-05-15
Date received
2012-06-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

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 & CO. KGNVZ358754358754Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-06-2701. H

Event Narratives#

D

Patient 1

BOSTON SCIENTIFIC RECEIVED INFO THAT THE RIGHT ATRIAL (RA) LEAD DISLODGED ONE DAY POST IMPLANT. A REVISION PROCEDURE WAS PERFORMED. THE LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED WITH ANOTHER MFR'S RA LEAD. NO ADD'L ADVERSE PT EFFECTS WERE REPORTED. THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

N

Patient 1

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS, THEREFORE, BASED ON THE INSP 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 MFG.