ACCOLADE MRI DR L311

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-30 for ACCOLADE MRI DR L311 manufactured by Boston Scientific Corporation.

MAUDE Entry Details

Report Number2124215-2019-25630
MDR Report Key9392347
Report SourceHEALTH PROFESSIONAL
Date Received2019-11-30
Date of Report2019-11-30
Date of Event2019-10-04
Date Mfgr Received2019-10-04
Device Manufacturer Date2019-04-15
Date Added to Maude2019-11-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTIMOTHY DEGROOT
Manufacturer Street4100 HAMLINE AVENUE NORTH
Manufacturer CitySAINT PAUL MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone6515826168
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer StreetCASHEL ROAD
Manufacturer CityCLONMEL
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACCOLADE MRI DR
Generic NameIMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
Product CodeLWP
Date Received2019-11-30
Model NumberL311
Catalog NumberL311
Lot Number418529
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address4100 HAMLINE AVENUE NORTH SAINT PAUL MN 55112 US 55112


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention 2019-11-30

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