FDA.reportPublic FDA data

MAUDE MDR 9817870

MDR report key
9817870
Report number
2017865-2020-03389
Event key
0
Event type
3
Date of event
2020-02-28
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
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
1VICTORY XL DRIMPLANTABLE PACEMAKER PULSE GENERATORST. JUDE MEDICAL, INC.(CRM-SYLMAR)DXY58165816R N

Patients#

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

Event Narratives#

N

Patient 1

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. THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A PACEMAKER REPLACEMENT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PACEMAKER HAD A LOOSE SET SCREW. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY CONSEQUENCES.