FDA.reportPublic FDA data

MAUDE MDR 9908596

MDR report key
9908596
Report number
2017865-2020-04503
Event key
0
Event type
3
Date of event
2020-03-20
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
ELIZABETH BOLTZ
Address
15900 VALLEY VIEW COURT SYLMAR CA 91342 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OPTISENSE LEADPERMANENT PACEMAKER ELECTRODEST. JUDE MEDICAL, INC.(CRM-SYLMAR)NVN1999/521999-523472751R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

THIS PRODUCT IS REGISTERED AS A COMBINATION PRODUCT. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE OPERATING ROOM FOR DEVICE EXCHANGE. DURING PROCEDURE, AN INSULATION BREACH WAS OBSERVED ON THE ATRIAL LEAD. A REPAIR KIT WAS USED TO COVER THE INSULATION BREACH. PATIENT WAS STABLE POST PROCEDURE.