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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II STEROX; IMPLANTABLE LEAD
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BOSTON SCIENTIFIC CORPORATION FINELINE II STEROX; IMPLANTABLE LEAD Back to Search Results
Model Number 4459
Medical Device Problem Codes Pacing Problem (1439); High Capture Threshold (3266)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/22/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) lead was capped and surgically abandoned due to high pacing thresholds and not delivering pacing when required.It was successfully replaced with a new lead.No additional adverse patient effects were reported.
 
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Brand Name
FINELINE II STEROX
Common Device Name
IMPLANTABLE LEAD
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key12551370
Report Number2124215-2021-24204
Device Sequence Number872455
Product Code DTB
UDI-Device Identifier00802526061004
UDI-Public00802526061004
Combination Product (Y/N)Y
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
P960004/S014
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/29/2021
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? Yes
Operator of Device Lay User/Patient
Device Expiration Date02/16/2012
Device Model Number4459
Device Catalogue Number4459
Device Lot Number465250
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/22/2021
Initial Report FDA Received Date09/30/2021
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 Age59 YR
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