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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II EZ STEROX; PERMANENT PACEMAKER ELECTRODE
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BOSTON SCIENTIFIC CORPORATION FINELINE II EZ STEROX; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 4474
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 02/11/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that this right ventricular (rv) lead was part of a system revision due to infection.There were no additional adverse patient effects reported.The rv lead was explanted.
 
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Brand Name
FINELINE II EZ STEROX
Common Device Name
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key11767243
Report Number2124215-2021-11456
Device Sequence Number3104560
Product Code DTB
UDI-Device Identifier00802526265037
UDI-Public00802526265037
Combination Product (Y/N)Y
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P960004/S014
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2004
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/03/2021
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 Date05/27/2006
Device Model Number4474
Device Catalogue Number4474
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/25/2021
Initial Report FDA Received Date05/03/2021
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 Age86 YR
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