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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 Unspecified Infection (1930); Pocket Erosion (2013); No Code Available (3191)
Date of Event 07/07/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.(b)(4).
 
Event or Problem Description
It was reported that this right ventricular (rv) lead was part of a system revision due to infection.The patient was treated with intravenous antibiotics.The patient also had systemic sclerosis and an unknown lead eroded through the skin.There was no allegation against the device and leads.There were no additional adverse patient effects reported.This rv lead was explanted.
 
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Brand Name
RELIANCE 4-FRONT
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key10796653
Report Number2124215-2020-24285
Device Sequence Number19679388
Product Code LWS
UDI-Device Identifier00802526496967
UDI-Public00802526496967
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/05/2020
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 Date12/06/2021
Device Model Number0665
Device Catalogue Number0665
Device Lot Number502950
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/07/2020
Initial Report FDA Received Date11/05/2020
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 Age44 YR
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