FDA.reportPublic FDA data

MAUDE MDR 2043664

MDR report key
2043664
Report number
1028232-2011-00588
Event key
0
Event type
3
Date of event
2011-02-23
Date received
2011-03-29
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
1LINOX S 65ICD LEADBIOTRONIK SE & CO. KGLWS351333351333* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-03-2901. H

Event Narratives#

D

Patient 1

AFTER AN IMPLANTATION TIME OF ABOUT 23 MONTHS, IT WAS REPORTED THAT THE ASSOCIATED ICD COULD NOT BE INTERROGATED. A SMALL FOCAL BURN MARK WAS DETECTED ON THE HOUSING DURING THE EXPLANTATION. THE ICD AND THE LEAD WERE EXPLANTED. THE DATE OF IMPLANT WAS NOT PROVIDED.