FDA.reportPublic FDA data

MAUDE MDR 9820964

MDR report key
9820964
Report number
3004936110-2020-00091
Event key
0
Event type
3
Date of event
2020-02-14
Date received
2020-03-11
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
STEPHANIE O' SULLIVAN
Address
5050 NATHAN LANE N PLYMOUTH MN 55442 US
Phone
651-651-6517
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HF SENSOR DELIVERY SYSTEMSYSTEM, HEMODYNAMIC, IMPLANTABLEST. JUDE MEDICAL, INC.MOMCM2000CM20007237992R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-110

Event Narratives#

N

Patient 1

THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT'S SENSOR HAD MIGRATED TO THE RIGHT VENTRICLE AS INDICATED BY THE SENSOR WAVEFORMS. A CHEST X-RAY WAS PLANNED TO ASSESS POSITIONING OF THE SENSOR. THE PATIENT EXPERIENCED NO ADVERSE CONSEQUENCES DUE TO THE REPORTED EVENT.