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

Model Number 4469

Device Problems Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Connection Problem (2900)

Patient Problem Bradycardia (1751)

Event Date 04/28/2022

Event Type  Injury  

Event Description

It was reported that this patient went through a revision procedure due to oversensing without pacing inhibition, loss of capture, and high out-of-range pacing impedance for both unipolar and bipolar configurations, in both the right atrial (ra) and right ventricular leads.Reportedly, impedance was jumpy/irregular on the atrial channel, while consistently high on the ventricular channel.The patient suffered sinus bradycardia as a result of these issues.Upon the revision procedure, both leads were tested in both configurations in the pacing system analyzer, and no abnormalities were found.Subsequently, the physician elected to only replace the pacemaker, because when the leads were connected to the new pacemaker, no issues were observed again.However, it was indicated that these issues were related to poor terminal pin to header connection.This ra lead remains in service and no additional adverse patient effects were reported.

• Brand Name: FINELINE II EZ STEROX
• Type of Device: IMPLANTABLE LEAD
• 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: 14690497
• MDR Text Key: 294011876
• Report Number: 2124215-2022-21208
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00802526265143
• UDI-Public: 00802526265143
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P960004/S014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2012
• Device Model Number: 4469
• Device Catalogue Number: 4469
• Device Lot Number: 529954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 34 YR
• Patient Sex: Male