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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE LEAD
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BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE LEAD Back to Search Results
Model Number 0652
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); No Code Available (3191)
Date of Event 12/04/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The product is not expected to return.(b)(4) captures the reportable event of surgery.
 
Event or Problem Description
It was reported that this right ventricular lead and all of the system were surgically explanted and replaced with a new system the same day due to infection.No additional adverse patient effects were reported.
 
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Brand Name
RELIANCE 4-FRONT
Common Device Name
IMPLANTABLE LEAD
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key11211981
Report Number2124215-2021-01389
Device Sequence Number2947469
Product Code LWS
UDI-Device Identifier00802526592812
UDI-Public00802526592812
Combination Product (Y/N)N
Initial Reporter StateIA
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,other
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/21/2021
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 Date09/27/2020
Device Model Number0652
Device Catalogue Number0652
Device Lot Number100865
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/04/2020
Initial Report FDA Received Date01/22/2021
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 Age74 YR
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