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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 Code Failure to Capture (1081)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/23/2021
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 surgically abandoned and replaced due to loss of capture.The cause of loss of capture was not determined.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 Key12620245
Report Number2124215-2021-26969
Device Sequence Number17193672
Product Code DTB
UDI-Device Identifier00802526061004
UDI-Public00802526061004
Combination Product (Y/N)Y
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
P960004/S014
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2005
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) 10/12/2021
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 Date08/27/2006
Device Model Number4459
Device Catalogue Number4459
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/23/2021
Initial Report FDA Received Date10/12/2021
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 Age83 YR
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