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

Model Number 4471

Device Problems Failure to Capture (1081); High Capture Threshold (3266)

Patient Problem Cardiac Perforation (2513)

Event Date 02/13/2024

Event Type  Injury  

Event Description

It was reported that this right ventricular (rv) lead exhibited high threshold measurements and loss of capture (loc).The root cause of the high threshold measurements and loc was suspected to be related to a lead perforation.A lead revision procedure was performed.The lead was successfully repositioned during the revision procedure.Approximately one week following the procedure, threshold measurements again increased.Rv outputs were then increased.The physician is considering an additional lead revision or replacement procedure.No additional procedure has been scheduled or undertaken at this time.No additional adverse patient effects were reported.This device remains in service.If pertinent information is provided in the future, a supplemental report will be submitted.

• Brand Name: FINELINE II EZ STEROX
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: 19000370
• MDR Text Key: 338882609
• Report Number: 2124215-2024-18919
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: P960004/S014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4471
• Device Catalogue Number: 4471
• Device Lot Number: 592711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 89 YR
• Patient Sex: Female