BIOMONITOR 2-AF 398493 SEE MODEL NO.

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-08 for BIOMONITOR 2-AF 398493 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.

MAUDE Entry Details

Report Number1028232-2019-04953
MDR Report Key9299971
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-08
Date of Report2019-11-05
Date of Event2019-10-11
Date Mfgr Received2019-11-08
Device Manufacturer Date2019-03-05
Date Added to Maude2019-11-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street6024 JEAN ROAD
Manufacturer CityLAKE OSWEGO OR 97035
Manufacturer CountryUS
Manufacturer Postal97035
Manufacturer Phone8772459800
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIOMONITOR 2-AF
Generic NameIMPLANTABLE CARDIAC MONITOR
Product CodeMXD
Date Received2019-11-08
Model Number398493
Catalog NumberSEE MODEL NO.
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOTRONIK SE & CO. KG
Manufacturer AddressWOERMANNKEHRE 1 BERLIN 12359 12359


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2019-11-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.