FDA.reportPublic FDA data

MAUDE MDR 2595341

MDR report key
2595341
Report number
1028232-2012-01296
Event key
0
Event type
3
Date of event
2012-04-18
Date received
2012-05-29
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 SMART SD 60/16ICD LEADBIOTRONIK ST & CO. KGLWS359065359065* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-05-2901. H

Event Narratives#

D

Patient 1

OUS MDR - NOISE WAS OBSERVED AND THE PHYSICIAN DECIDED TO RE-OPEN THE POCKET ON (B)(6) 2012. DURING THE LEAD EXPLANTATION, A STYLET INTENDED FOR USE WITH THE LEAD COULD NOT BE ADVANCED TOWARDS THE LEAD TIP. THEREFORE ANOTHER STYLET (NOT BIOTRONIK) WAS USED AND THE LEAD WAS EXPLANTED PROPERLY. THE LEAD WILL BE RETURNED WITH THE STYLET.

N

Patient 1

OUS MDR.