FDA.reportPublic FDA data

MAUDE MDR 2848123

MDR report key
2848123
Report number
1028232-2012-02891
Event key
0
Event type
3
Date of event
2011-12-13
Date received
2012-11-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

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
1EVIA DR-TPACEMAKERBIOTRONIK SE & CO. KGNVZ359529359529* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-11-2101. H

Event Narratives#

D

Patient 1

THE PT DEVELOPED PAIN AROUND THE POCKET SITE AND DOWN HIS ARM. THE PT HAD A POSSIBLE ALLERGIC REACTION TO THE PACEMAKER SYSTEM. THE SYSTEM WAS EXPLANTED ON (B)(6) 2011 AND NOT REPLACED AS THE PT WAS DEEMED INTOLERANT OF IMPLANTED DEVICES. THERE ARE NO KNOWN COMPLAINTS ASSOCIATED WITH THE FUNCTIONALITY OF THIS DEVICE. THIS DEVICE REMAINS AT THE HOSPITAL. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.