DYNAGEN EL ICD DR D152

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 2020-03-30 for DYNAGEN EL ICD DR D152 manufactured by Boston Scientific Corporation.

Event Text Entries

[186308703] As no further information concerning this report is expected, our investigation is complete. This investigation will be updated should further information be provided.
Patient Sequence No: 1, Text Type: N, H10


[186308704] It was reported that this implantable cardioverter defibrillator (icd) was part of a system revision due to infection and pocket erosion. Reportedly, the device was exposed. There were no additional adverse patient effects reported. The icd was explanted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2124215-2020-05598
MDR Report Key9901578
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-01-21
Date Mfgr Received2020-01-21
Device Manufacturer Date2018-04-20
Date Added to Maude2020-03-30
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 NameDYNAGEN EL ICD DR
Generic NameIMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Product CodeLWS
Date Received2020-03-30
Returned To Mfg2020-01-29
Model NumberD152
Catalog NumberD152
Lot Number544812
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrN
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. Required No Informationntervention 2020-03-30

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