MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 3 IS-1; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	4549
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that electrogram (egm) review was requested due left ventricular (lv) lead loss of capture (loc) concerns based on a presenting egm from (b)(6) 2024.When compared to a prior presenting egm from (b)(6) 2023, the morphology was different and the configuration was the same.Further evaluation was recommended.The lv lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding event cause and resolution.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding event cause and resolution.If information is provided in the future, a supplemental report will be issued.If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that electrogram (egm) review was requested due left ventricular (lv) lead loss of capture (loc) concerns based on a presenting egm from (b)(6) 2024.When compared to a prior presenting egm from (b)(6) 2023, the morphology was different and the configuration was the same.Further evaluation was recommended.The lv lead remains in service.No adverse patient effects were reported.Additional information received reported that the cardiac resynchronization therapy pacemaker (crt-p) replacement procedure due to safety mode was completed successfully and all leads were fine.This lv lead remains in service.No additional adverse patient effects were reported.

• Brand Name: EASYTRAK 3 IS-1
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 19209783
• Report Number: 2124215-2024-25883
• Device Sequence Number: 15462515
• Product Code: LWP
• UDI-Device Identifier: 00802526420399
• UDI-Public: 00802526420399
• Combination Product (Y/N): Y
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/20/2016
• Device Model Number: 4549
• Device Catalogue Number: 4549
• Device Lot Number: 185741
• 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: 04/11/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2014
• 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
• Patient Age: 80 YR
• Patient Sex: Male