FDA.reportPublic FDA data

MAUDE MDR 9908125

MDR report key
9908125
Report number
2649622-2020-06725
Event key
0
Event type
3
Date of event
2020-03-07
Date received
2020-03-31
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#

Contact
PAULA BIXBY
Address
8200 CORAL SEA ST NE MOUNDS VIEW MN 55112 US
Phone
763-763-7635
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CAPSUREFIX NOVUS LEAD MRI SURESCANELECTRODE, PACEMAKER, PERMANENTMPRIDTB5076-455076-45* N

Patients#

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

Event Narratives#

N

Patient 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

IT WAS REPORTED THAT INTERMITTENT UNDER-SENSING NOTED ON ATRIAL CHANNEL ON STORED ELECTROGRAM AT TIMES CAUSING PREMATURE TERMINATION OF MODE SWITCH. THE RIGHT ATRIAL (RA) LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.