MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENERGEN CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

Model Number	N140
Medical Device Problem Codes	High impedance (1291); Failure to Read Input Signal (1581); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) system was to undergo magnetic resonance imaging (mri).Technical services (ts) was consulted and discussed this system is non-conditional due to out-of-range impedance measurements for its right atrial (ra) lead and left ventricular (lv) lead.The ra lead exhibited low out of range impedance measurements.The lv lead exhibited high out of range impedance measurements.Additionally, low amplitude was noted for its ra lead.This crt-d remains in service.No adverse patient effects were reported.

• Brand Name: ENERGEN CRT-D
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 21322789
• Report Number: 2124215-2025-06451
• Device Sequence Number: 8062682
• Product Code: LWP
• UDI-Device Identifier: 00802526480959
• UDI-Public: 00802526480959
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2025

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: 09/05/2016
• Device Model Number: N140
• Device Catalogue Number: N140
• Device Lot Number: 115390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 02/06/2025
• Date Device Manufactured: 09/12/2014
• 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: 59 YR
• Patient Sex: Male