FDA.reportPublic FDA data

MAUDE MDR 9334845

MDR report key
9334845
Report number
1220908-2019-03562
Event key
0
Event type
3
Date received
2019-11-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
269 MILL ROAD CHELMSFORD MA 01824 US
Phone
978-978-9784
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1X SERIESDEFIBRILLATOR/PACEMAKERZOLL MEDICAL CORPORATIONDRTX SERIESX SERIESNAR R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-180

Event Narratives#

No narrative records found.