FDA.reportPublic FDA data

MAUDE MDR 2603381

MDR report key
2603381
Report number
1028232-2012-01479
Event key
0
Event type
3
Date of event
2012-02-09
Date received
2012-06-04
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
1LUMAX 540 DR-TICDBIOTRONIK SE & CO. KGMRM360346360346* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-06-0401. D

Event Narratives#

D

Patient 1

THIS PT EXPIRED ON (B)(6) 2012. THE FAMILY IS QUESTIONING THE FUNCTIONALITY OF THIS DEVICE, HOWEVER THIS DEVICE HAS NOT BEEN RETURNED. THE FOLLOWING PHYSICIAN'S OFFICE HAS NOT SEEN THIS PT SINCE IMPLANT. THE PT EXPIRED AT A CARE CENTER AND THEY WILL NOT RELEASE INFO REGARDING THIS PT'S DEATH. SHOULD ADD'L INFO BECOME AVAILABLE. THIS FILE WILL BE UPDATED.