FDA.reportPublic FDA data

MAUDE MDR 2398852

MDR report key
2398852
Report number
1028232-2011-03153
Event key
0
Event type
3
Date of event
2011-10-06
Date received
2011-12-27
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
1KENTROX RV-S 65 STEROIDICD LEADBIOTRONIK SE & CO. KGLWS343080343080* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-12-2701. H

Event Narratives#

D

Patient 1

OUS MDR - AFTER AN IMPLANT DURATION OF APPROXIMATELY 71 MONTHS, OVERSENSING WAS REPORTED. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED. THE DEVICE WAS EXPLANTED.

N

Patient 1

OUS MDR.