FDA.reportPublic FDA data

MAUDE MDR 2367274

MDR report key
2367274
Report number
1028232-2011-02643
Event key
0
Event type
3
Date of event
2011-09-13
Date received
2011-11-10
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 4135PACEER LEADBIOTRONIC SE & CO., KG.NVZ358744358744R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-11-1001. H

Event Narratives#

D

Patient 1

BOSTON SCIENTIFIC RECEIVED INFO THAT THIS RIGHT ATRIAL LEAD WAS EXPLANTED AND REPLACED DUE TO DISLODGEMENT, LEAD DAMAGE AND INSULATION DAMAGE. THERE WAS NO REPORT OF ADVERSE PT EFFECTS DUE TO THE EXPLANT PROCEDURE. AS OF TODAY, THE EXPLANTED PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. IF THE PRODUCT IS RETURNED OR IF ADD'L INFO BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

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 MFG.