FDA.reportPublic FDA data

MAUDE MDR 2253980

MDR report key
2253980
Report number
1028232-2011-02112
Event key
0
Event type
3
Date of event
2011-07-22
Date received
2011-09-14
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
1DESTRUS 4137PACER LEADBIOTRONIK SE & CO. KGNVZ358764358764R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-09-1401. H

Event Narratives#

D

Patient 1

BOSTON SCIENTIFIC RECEIVED INFO THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS REPOSITIONED AFTER POCKET CLOSURE DUE TO R-WAVES THAT WERE 2.5MV IN BOTH BIPOLAR AND UNIPOLAR CONFIGURATION WITH CAPTURE THRESHOLD OF 0.70V AT .40MS. LEAD WAS SUCCESSFULLY REPOSITIONED. THERE WERE NO ADVERSE PT EFFECTS REPORTED. LEAD REMAINS IMPLANTED. 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 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.