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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II STEROX; PERMANENT PACEMAKER ELECTRODE
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BOSTON SCIENTIFIC CORPORATION FINELINE II STEROX; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 4458
Medical Device Problem Codes Failure to Capture (1081); High impedance (1291); Device Sensing Problem (2917)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/01/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited loss of capture, noise, and high out of range impedance that spiked over 2500 ohms.The patient underwent surgical intervention to surgically abandon the lead.A new lead was implanted.No additional adverse patient effects were reported.
 
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Brand Name
FINELINE II STEROX
Common Device Name
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key9576854
Report Number2124215-2019-27959
Device Sequence Number2865974
Product Code DTB
UDI-Device Identifier00802526060953
UDI-Public00802526060953
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
P960004/S014
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/10/2020
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? Yes
Operator of Device Lay User/Patient
Device Expiration Date01/27/2012
Device Model Number4458
Device Catalogue Number4458
Device Lot Number419668
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/07/2019
Initial Report FDA Received Date01/10/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Life Threatening; Required Intervention;
Patient Age85 YR
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