FDA.reportPublic FDA data

MAUDE MDR 9391607

MDR report key
9391607
Report number
9614453-2019-03998
Event key
0
Event type
3
Date of event
2019-11-15
Date received
2019-11-29
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
1ENRHYTHM MRI SURESCANPULSE GENERATOR, PERMANENT, IMPLANTABLEMEDTRONIC EUROPE SARLNVZEMDR01EMDR01* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-2901. H; 2. R

Event Narratives#

No narrative records found.