FDA.reportPublic FDA data

MAUDE MDR 9701508

MDR report key
9701508
Report number
1028232-2020-00696
Event key
0
Event type
3
Date of event
2020-02-07
Date received
2020-02-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
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
1LUMAX 740 DR-TICDBIOTRONIK SE & CO. KGMRM365606SEE MODEL NO.* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-1201. H

Event Narratives#

D

Patient 1

THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO EOS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.