ENDOTAK RELIANCE G 0296

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-30 for ENDOTAK RELIANCE G 0296 manufactured by Boston Scientific Corporation.

MAUDE Entry Details

Report Number2124215-2019-24452
MDR Report Key9392286
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-30
Date of Report2019-11-30
Date of Event2019-06-25
Date Mfgr Received2019-06-26
Device Manufacturer Date2017-04-10
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 StreetROAD 698, LOT NO. 12
Manufacturer CityDORADO PR 00646-260
Manufacturer Postal Code00646-2602
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENDOTAK RELIANCE G
Generic NamePERMANENT DEFIBRILLATOR ELECTRODES
Product CodeNVY
Date Received2019-11-30
Returned To Mfg2019-07-17
Model Number0296
Catalog Number0296
Lot Number414725
Device Expiration Date2019-04-10
OperatorLAY USER/PATIENT
Device AvailabilityR
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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