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

Model Number	4548
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Device Overstimulation of Tissue (1991)
Date of Event	03/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient implanted with this left ventricular (lv) lead experienced chronic diaphragmatic stimulation and resulting pacing output needing to be reprogrammed at or below threshold for adequate cardiac resynchronization therapy (crt) delivery.The patient was already scheduled for extraction and re-implant.Additional information indicated that the lead was surgically explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.

• 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: 16794105
• Report Number: 2124215-2023-19385
• Device Sequence Number: 12480247
• Product Code: LWP
• UDI-Device Identifier: 00802526420276
• UDI-Public: 00802526420276
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/24/2023

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: 09/10/2015
• Device Model Number: 4548
• Device Catalogue Number: 4548
• Device Lot Number: 172492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2013
• 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: 72 YR
• Patient Sex: Male