FDA.reportPublic FDA data

MAUDE MDR 8981304

MDR report key
8981304
Report number
1000165971-2019-00534
Event key
0
Event type
3
Date of event
2019-08-12
Date received
2019-09-10
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#

Contact
ELODIE VINCENT
Address
PARC D'AFFAIRES NOVEOS 4 AVENUE R . CLAMART 92140 FR
Phone
14-14-0146
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SMARTVIEWPACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTSSORIN GROUP ITALIA S.R.L. - CRM FACILITYOSRSMARTVIEW PSTNSMARTVIEW PSTNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-09-100

Event Narratives#

No narrative records found.