FDA.reportPublic FDA data

MAUDE MDR 2568240

MDR report key
2568240
Report number
1028232-2012-01153
Event key
0
Event type
3
Date of event
2012-04-16
Date received
2012-05-04
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 53PACER LEADBIOTRONIK SE & CO. KGDTB350974350974* N

Patients#

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

Event Narratives#

D

Patient 1

UPON INTERROGATION THE DEVICE REPORTED AN ERROR MESSAGE REGARDING AN EXCESSIVE BATTERY DRAIN. ON (B)(6) 2012 - WE WERE INFORMED THAT THIS PACEMAKER AND THE ATRIAL LEAD WERE REPLACED ON (B)(6) 2012. ON (B)(6) 2012 - WE WERE INFORMED THAT THE ASSOCIATED ATRIAL LEAD WAS CAPPED DUE TO POSSIBLE CRUSH.