MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II EZ STEROX; IMPLANTABLE LEAD

Model Number	4472
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291); Over-Sensing (1438); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with the pacemaker device exhibited noisy on this right atrial (ra) channel.There was a signal artifact monitor (sam) episode noted and the electrogram (egm) showed ra impedance measurements, measuring less than 200 ohms few months ago.Later, the ra impedances were greater than 3000 ohms.It was suspected that there was right atrial (ra) lead degradation.Technical services (ts) recommended to reduce ra sensitivity and consider lead revision.Boston scientific representative stated that the physician was leaning toward ra lead revision procedure, however no decision yet is made.This ra lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This report contains additional information in section b5 describe event or problem and h6 device codes.This report contains additional information in section b1 adverse event/product problem, b2 outcomes attrib to adv event, b5 describe event or problem, d6b explant date, h1 type of reportable event, h2 if follow-up, what type and h6 impact codes.
Event or Problem Description
It was reported that the patient with the pacemaker device exhibited noisy on this right atrial (ra) channel.There was a signal artifact monitor (sam) episode noted and the electrogram (egm) showed ra impedance measurements, measuring less than 200 ohms few months ago.Later, the ra impedances were greater than 3000 ohms.It was suspected that there was right atrial (ra) lead degradation.Technical services (ts) recommended to reduce ra sensitivity and consider lead revision.Boston scientific representative stated that the physician was leaning toward ra lead revision procedure, however no decision yet is made.This ra lead remains in service.No adverse patient effects were reported.Additional information received indicated that this lead was explanted and successfully replaced as this lead was fractured.No additional patient adverse effects were reported.The lead is expected to return for analysis.
Additional Manufacturer Narrative
This report contains additional information in section b1 adverse event/product problem, b2 outcomes attrib to adv event, b5 describe event or problem, d6b explant date, h1 type of reportable event, h2 if follow-up, what type and h6 impact codes.
Event or Problem Description
It was reported that the patient with the pacemaker device exhibited noisy on this right atrial (ra) channel.There was a signal artifact monitor (sam) episode noted and the electrogram (egm) showed ra impedance measurements, measuring less than 200 ohms few months ago.Later, the ra impedances were greater than 3000 ohms.It was suspected that there was right atrial (ra) lead degradation.Technical services (ts) recommended to reduce ra sensitivity and consider lead revision.Boston scientific representative stated that the physician was leaning toward ra lead revision procedure, however no decision yet is made.This ra lead remains in service.No adverse patient effects were reported.Additional information received indicated that this lead was explanted and successfully replaced.No additional patient adverse effects were reported.
Additional Manufacturer Narrative
The returned lead was analyzed.Visual inspection of the lead noted both the internal and the external insulation was abraded through to the conductor coil.Microscopic evaluation indicated that the insulation damage was caused by localized compressive stress on the insulation surface.Due to the location and the type of damage exhibited, it was concluded that the damage was caused by lead entrapment in the clavicle/first-rib region.
Event or Problem Description
It was reported that the patient with the pacemaker device exhibited noisy on this right atrial (ra) channel.There was a signal artifact monitor (sam) episode noted and the electrogram (egm) showed ra impedance measurements, measuring less than 200 ohms few months ago.Later, the ra impedances were greater than 3000 ohms.It was suspected that there was right atrial (ra) lead degradation.Technical services (ts) recommended to reduce ra sensitivity and consider lead revision.Boston scientific representative stated that the physician was leaning toward ra lead revision procedure, however no decision yet is made.This ra lead remains in service.No adverse patient effects were reported.Additional information received indicated that this lead was explanted and successfully replaced as this lead was fractured.No additional patient adverse effects were reported.The lead is expected to return for analysis.

• Brand Name: FINELINE II EZ STEROX
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18640138
• Report Number: 2124215-2024-06195
• Device Sequence Number: 12755893
• Product Code: DTB
• UDI-Device Identifier: 00802526265013
• UDI-Public: 00802526265013
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P960004/S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/21/2025

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 Date: 04/06/2007
• Device Model Number: 4472
• Device Catalogue Number: 4472
• Device Lot Number: 416951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: 12/04/2024; 12/10/2024; 03/19/2025
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 12/10/2024; 12/10/2024; 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2005
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female