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

Model Number	4474
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528)
Health Effect - Clinical Codes	Unspecified Infection (1930); Foreign Body In Patient (2687)
Date of Event	06/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient with this right ventricular (rv) lead had an infection.A revision was performed and the pacemaker was explanted while the right ventricular (rv) lead and right atrial (ra) lead were capped.In addition, the tip of the leads were retained in the heart following the procedure.The physician fractured the leads in an attempt to extract them.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that the patient with this right ventricular (rv) lead had an infection.A revision was performed and the pacemaker was explanted while the right ventricular (rv) lead and right atrial (ra) lead were capped.In addition, the tip of the leads were retained in the heart following the procedure.The physician fractured the leads in an attempt to extract them.Multiple attempts were made to get all parts of the lead, but were unsuccessful.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.Correction to field b5: describe event or problem, f10: device codes and h6: device codes.
Event or Problem Description
It was reported that the patient with this right ventricular (rv) lead had an infection.A revision was performed and the pacemaker was explanted while the right ventricular (rv) lead and right atrial (ra) lead were capped.In addition, the tip of the leads were retained in the heart following the procedure.The physician fractured the leads in an attempt to extract them.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.Correction to field b5: describe event or problem, f10: device codes and h6: device codes.

• Brand Name: FINELINE II EZ 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: 14913779
• Report Number: 2124215-2022-24039
• Device Sequence Number: 2031677
• Product Code: DTB
• UDI-Device Identifier: 00802526265037
• UDI-Public: 00802526265037
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P960004/S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• 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): 08/17/2022

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: 08/01/2004
• Device Model Number: 4474
• Device Catalogue Number: 4474
• 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: 06/20/2022
• Supplement Date Received by Manufacturer: 06/20/2022; 07/28/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 07/07/2022; 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2002
• 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: 66 YR
• Patient Sex: Male