FDA.reportPublic FDA data

MAUDE MDR 2562018

MDR report key
2562018
Report number
1028232-2012-01011
Event key
0
Event type
3
Date of event
2012-04-06
Date received
2012-04-27
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
1LINOX SMART S 65ICD LEADBIOTRONIK SE & CO. KGLWS369818369818* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-04-2701. H

Event Narratives#

D

Patient 1

THIS LEAD WAS REMOVED AND REPLACED BECAUSE IT HAS BEEN REPOSITIONED TWICE AND NEEDED TO BE REPOSITIONED AGAIN. THERE ARE NO ADVERSE EVENTS REPORTED FOR THIS PT. THE HOSPITAL RETAINED THIS DEVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS FILE WILL BE UPDATED.