MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II STEROX; PERMANENT PACEMAKER ELECTRODE

Model Number	4459
Medical Device Problem Codes	High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited a gradual rise in pace impedance measurements up to an out of range measurement of 1,803 ohms.It was noted that rv impedance was 1,346 ohms on (b)(6) 2021.Previous in-office threshold measurement from 2019 was 2.2@0.4ms, and now rv output was fixed at 4v@0.5ms.Technical services (ts) recommended further lead evaluation and checking unipolar configuration for potentially better lead measurements.This rv lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
The local area field representative was contacted for additional information.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 exhibited a gradual rise in pace impedance measurements up to an out of range measurement of 1,803 ohms.It was noted that rv impedance was 1,346 ohms on june 22, 2021.Previous in-office threshold measurement from 2019 was 2.2@0.4ms, and now rv output was fixed at 4v@0.5ms.Technical services (ts) recommended further lead evaluation and checking unipolar configuration for potentially better lead measurements.This rv lead remains in service.No adverse patient effects were reported.Additional information received reported that this right ventricular (rv) lead was surgically abandoned and replaced.The pacemaker was also explanted and upgraded to a cardiac resynchronization therapy defibrillator (crt-d).No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.-- if information is provided in the future, a supplemental report will be issued.

• 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
• 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: 14999035
• Report Number: 2124215-2022-25403
• Device Sequence Number: 11232874
• Product Code: DTB
• UDI-Device Identifier: 00802526061004
• UDI-Public: 00802526061004
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022

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: 08/18/2005
• Device Model Number: 4459
• Device Catalogue Number: 4459
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2003
• 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: 67 YR
• Patient Sex: Male