FDA.reportPublic FDA data

MAUDE MDR 2860128

MDR report key
2860128
Report number
1028232-2012-03012
Event key
0
Event type
3
Date of event
2012-11-08
Date received
2012-11-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
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
1SETROX S 60PACER LEADBIOTRONIK SE & CO. KGNVZ350975350975* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-11-2901. H

Event Narratives#

D

Patient 1

THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT. THERE WAS LOSS OF CAPTURE AND LOSS OF SENSING. THE LEAD WAS NOT REPLACED DUE TO INTACT CONDUCTION. THE PHYSICIAN STATED THAT "THERE APPEARS TO BE AN ABRADED AREA ON THE LEAD WHERE THE EXPOSED SCREW MAY HAVE BEEN RUBBING AGAINST THE LEAD BODY FOR SEVERAL MONTHS". THERE WERE NO ADVERSE EVENTS REPORTED FOR THE PT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.