FDA.reportPublic FDA data

MAUDE MDR 9888767

MDR report key
9888767
Report number
9612164-2020-01379
Event key
0
Event type
3
Date of event
2020-03-18
Date received
2020-03-27
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
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
1MICRALEADLESS PACEMAKERMEDTRONIC IRELANDPNJMC1VR01MC1VR01* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2701. H; 2. R

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 THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED HIGH THRESHOLDS AND INTERMITTENT CAPTURE ON THE FIRST POST IMPLANT DAY. THE LEADLESS IPG WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.