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

Model Number	4474
Medical Device Problem Codes	Failure to Capture (1081); Over-Sensing (1438); Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the emergency department after a fall.Loss of capture (loc) for an unknown duration was observed on this right ventricular (rv) lead.The patient was reported to be 62 percent ventricular paced and was noted to be in atrial fibrillation (af) with the device programmed vvi as a result.An attempt was made to assess the presenting rhythm, however, review of the presenting electrogram (egm) showed the atrial signals over the ventricular channel.The physician noted that an x-ray was performed and would be reviewed to assess lead placement.Additional information from the local field representative noted that the patient was found to be in af with rates in the 70-80 beats per minute (bpm) range.No additional information was obtained regarding the root cause of the loc or outcome of the x-ray.The patient was then discharged from the hospital and has not been in contact with their following physician since.No adverse patient effects were reported.This device remains in service.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
This report is being filed to correct field h6: device codes.
Event or Problem Description
It was reported that the patient presented to the emergency department after a fall.Loss of capture (loc) for an unknown duration was observed on this right ventricular (rv) lead.The patient was reported to be 62 percent ventricular paced and was noted to be in atrial fibrillation (af) with the device programmed vvi as a result.An attempt was made to assess the presenting rhythm, however, review of the presenting electrogram (egm) showed the atrial signals over the ventricular channel.The physician noted that an x-ray was performed and would be reviewed to assess lead placement.Additional information from the local field representative noted that the patient was found to be in af with rates in the 70-80 beats per minute (bpm) range.No additional information was obtained regarding the root cause of the loc or outcome of the x-ray.The patient was then discharged from the hospital and has not been in contact with their following physician since.No adverse patient effects were reported.This device remains in service.If information is provided in the future, a supplemental report will be issued.

• 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): 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: 14107838
• Report Number: 2124215-2022-09997
• Device Sequence Number: 20030988
• Product Code: DTB
• UDI-Device Identifier: 00802526265037
• UDI-Public: 00802526265037
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P960004/S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2022

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: 05/30/2011
• Device Model Number: 4474
• Device Catalogue Number: 4474
• Device Lot Number: 427681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 05/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2009
• 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
• Patient Sex: Male