FDA.reportPublic FDA data

MAUDE MDR 9392290

MDR report key
9392290
Report number
2124215-2019-24457
Event key
0
Event type
3
Date of event
2019-06-25
Date received
2019-11-30
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
TIMOTHY DEGROOT
Address
4100 HAMLINE AVENUE NORTH SAINT PAUL MN 55112 US
Phone
651-651-6515
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ACUITY X4 SPIRAL SIMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)BOSTON SCIENTIFIC CORPORATIONLWP46744674605573R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-3001. H; 2. L; 3. R

Event Narratives#

No narrative records found.