FDA.reportPublic FDA data

MAUDE MDR 2568230

MDR report key
2568230
Report number
1028232-2012-01108
Event key
0
Event type
3
Date of event
2011-03-11
Date received
2012-05-04
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. KGDTB358754358754R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-05-0401. H

Event Narratives#

D

Patient 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE CHECK, IT WAS OBSERVED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NO CAPTURE. APPROXIMATELY NINE MONTHS LATER, DURING A ROUTINE DEVICE CHECK, THE RV LEAD WAS NOT PACING. AN AV NODAL ABLATION PROCEDURE WAS PERFORMED AND NO UNDERLYING RHYTHM WAS OBSERVED, WITH ONLY LEFT VENTRICULAR (LV) PACING OCCURRING. THE PT REPORTEDLY SUFFERED NO SYMPTOMS AND WAS PACED 100% OFF THE LV LEAD. THE RV LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED DUE TO NO CAPTURE. NO ADVERSE PT EFFECTS WERE REPORTED DURING THE PROCEDURE. THE LEAD WAS RETURNED TO ALLOW FOR RELIABILITY ANALYSIS.

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 CONDIMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.