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

Model Number	4474
Medical Device Problem Codes	High impedance (1291); Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high out of range pacing impedance measurements of greater than 3000 ohms.There was no noise observed during isometric testing.The lead safety switch (lss) was triggered, and the setting was changed to unipolar.It was also noted that the pacing rate had been gradually increasing of a time period of six months.A pacemaker system changeout has been scheduled.No adverse patient effects were reported.Currently, this lead remains in service.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high out of range pacing impedance measurements of greater than 3000 ohms.There was no noise observed during isometric testing.The lead safety switch (lss) was triggered, and the setting was changed to unipolar.It was also noted that the pacing rate had been gradually increasing of a time period of six months.A pacemaker system changeout has been scheduled.No adverse patient effects were reported.Currently, this lead remains in service.According to additional information received, this lead was surgically abandoned during generator changeout procedure, and a new rv lead was successfully placed.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): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15657566
• Report Number: 2124215-2022-43038
• Device Sequence Number: 6463442
• Product Code: DTB
• UDI-Device Identifier: 00802526265037
• UDI-Public: 00802526265037
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P960004/S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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: 09/08/2011
• Device Model Number: 4474
• Device Catalogue Number: 4474
• Device Lot Number: 428064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2009
• 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: Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female