DYNAGEN EL ICD DR D153

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-30 for DYNAGEN EL ICD DR D153 manufactured by Boston Scientific Corporation.

Event Text Entries

[186375315] It was reported that this implantable cardioverter defibrillator (icd) patient experienced ventricular tachycardia (vt). Anti-tachycardia pacing (atp) was delivered, and the third burst accelerated the patient's rhythm into ventricular fibrillation (vf). The device delivered a shock, which successfully converted the rhythm. Boston scientific technical services (ts) discussed reprogramming options. This icd remains in service. No additional adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2124215-2020-03216
MDR Report Key9901574
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-01-23
Date Mfgr Received2020-01-23
Device Manufacturer Date2016-08-03
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
Model NumberD153
Catalog NumberD153
Lot Number205367
Device Expiration Date2018-07-22
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. Life Threatening 2020-03-30

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