FDA.reportPublic FDA data

MAUDE MDR 2057951

MDR report key
2057951
Report number
1028232-2011-00815
Event key
0
Event type
3
Date of event
2011-02-11
Date received
2011-04-07
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 4137PACER LEADBIOTRONIK SE & CO. KGNVZ358764358764R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-04-0701. H

Event Narratives#

D

Patient 1

BOSTON SCIENTIFIC RECEIVED INFO THAT THIS PT REPORTS HIS RIGHT VENTRICULAR LEAD DISLODGED. HE STATED THAT FIVE WEEKS POST IMPLANT, AN X-RAY CONFIRMED MOVEMENT AND HIGHER THRESHOLDS WERE NOTED AT 1.7V. THE PT WAS ALSO INQUIRING ABOUT CLAVICULAR CRUSH, LONGEVITY OF LEAD AND IF THE LEAD SHOULD BE REMOVED. PT SERVICES DISCUSSED THE PT'S CONCERNS AND REFERRED THE PT TO THEIR PHYSICIAN. NO ADVERSE PT EFFECTS WERE REPORTED. THE LEAD REMAINS IN SERVICE. 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 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.