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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number 0665
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pulmonary Embolism (1498); Unspecified Infection (1930)
Date of Event 03/04/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
Event or Problem Description
It was reported that this right ventricular (rv) lead was part of a system revision due to infection.In addition, the patient had also a pulmonary embolism and was put on tissue plasminogen activator and heparin.This rv lead was explanted.No additional adverse patient effects were reported.
 
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Brand Name
RELIANCE 4-FRONT
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key9982018
Report Number2124215-2020-08570
Device Sequence Number4483537
Product Code LWS
UDI-Device Identifier00802526496967
UDI-Public00802526496967
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Expiration Date12/11/2021
Device Model Number0665
Device Catalogue Number0665
Device Lot Number503128
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/04/2020
Initial Report FDA Received Date04/21/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age65 YR
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