FDA.reportPublic FDA data

MAUDE MDR 9901382

MDR report key
9901382
Report number
2017865-2020-03702
Event key
0
Event type
3
Date of event
2020-03-11
Date received
2020-03-30
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
1DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTORDEFIBRILLATION LEADST. JUDE MEDICAL, INC.(CRM-SYLMAR)NVY7122Q/587122Q-58A000086348R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3001. R

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

RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2020-03704. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC DUE TO BRIEF EPISODES OF ASYSTOLE. DEVICE INTERROGATION SHOWED THE RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE DUE TO DISLODGEMENT. HIGH CAPTURE THRESHOLDS WERE ALSO NOTED ON THE LV LEAD. THE PHYSICIAN RE-POSITIONED THE LEADS ON (B)(6) 2020. THE PATIENT WAS STABLE BEFORE, DURING AND AFTER THE PROCEDURE.