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

Model Number	4472
Medical Device Problem Codes	Fracture (1260); High impedance (1291); No Apparent Adverse Event (3189); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this lead was surgically abandoned due to an unknown product performance issue.A new lead was implanted.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this lead was surgically abandoned due to impedance measurements over 3000 ohms, high capture thresholds and fracture.A new lead was implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Corrected fields: b5.Describe event or problem h6.Device codes.
Additional Manufacturer Narrative
Corrected fields: b5.Describe event or problem.H6.Device codes.
Event or Problem Description
It was reported that this lead was surgically abandoned due to impedance measurements over 3000 ohms, high capture thresholds and fracture.A new lead was implanted.No additional adverse patient effects were reported.

• 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): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18980505
• Report Number: 2124215-2024-18236
• Device Sequence Number: 6299487
• Product Code: DTB
• UDI-Device Identifier: 00802526265013
• UDI-Public: 00802526265013
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P960004/S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2024

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: 02/10/2005
• Device Model Number: 4472
• Device Catalogue Number: 4472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: Not provided; 04/29/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 04/01/2024; 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2003
• 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: 83 YR
• Patient Sex: Female