FDA.reportPublic FDA data

MAUDE MDR 2485077

MDR report key
2485077
Report number
1028232-2012-00521
Event key
0
Event type
3
Date of event
2012-02-09
Date received
2012-03-05
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
1LUMAX 540 DR-TICDBIOTRONIK SE & CO. KGMRM360346360346* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-03-0501. D

Event Narratives#

D

Patient 1

(B)(4) MDR - AFTER AN IMPLANT DURATION OF ABOUT 11 MONTHS, IT WAS REPORTED THAT THE PT WAS EXTERNALLY DEFIBRILLATED. AFTER THE EXTERNAL DEFIBRILLATION THE DEVICE COULD NOT BE INTERROGATED. THE PT EXPIRED THE FOLLOWING DAY. THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. THIS IS ALL THE INFO THAT IS AVAILABLE TO US. NO CAUSE OF DEATH WAS REPORTED.

N

Patient 1

(B)(4) MDR.