FDA.reportPublic FDA data

MAUDE MDR 2261918

MDR report key
2261918
Report number
1028232-2011-02151
Event key
0
Event type
3
Date of event
2011-08-29
Date received
2011-09-20
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 45PACER LEADBIOTRONIK SE & CO. KGNVZ350973350973* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-09-2001. O

Event Narratives#

D

Patient 1

THIS PATIENT WAS FEELING POORLY. A DEVICE CHECK REVEALED HIGH THRESHOLD MEASUREMENTS AND CXR CONFIRMED LEAD DISLODGEMENT. THIS PATIENT IS SCHEDULED FOR A LEAD REVISION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.