FDA.reportPublic FDA data

MAUDE MDR 2369046

MDR report key
2369046
Report number
1028232-2011-02911
Event key
0
Event type
3
Date of event
2011-10-18
Date received
2011-12-07
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 LEADBIOTORNIK SE & CO. KGNVZ358754358754R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-12-0701. H

Event Narratives#

D

Patient 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT ATRIAL (RA) LEAD IS SUSPECTED TO HAVE A MICRO DISLODGEMENT DUE TO INCREASED THRESHOLD MEASUREMENTS OF 4.5V AT 1.0MS. IT WAS NOTED THAT THE RA LEAD SENSING AND IMPEDANCE MEASUREMENTS WERE STABLE AT 0.7MV AND 460 OHMS. THE RA LEAD WAS EXPLANTED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. ACCESS FOR THE NEW LEAD WAS ACHIEVED BY STICKING AN 0.35 NEEDLE IN THE INSULATION OF THIS LEAD. NO ADVERSE PT EFFECTS WERE REPORTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION 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 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.