MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENERGEN CRT-D; IMPLANTABLE DEVICE

Model Number	N141
Medical Device Problem Codes	Off-Label Use (1494); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an explant procedure when they took the cardiac resynchronization therapy defibrillator (crt-d) out of the pocket they lost pacing on both the right ventricular (rv) and left ventricular (lv) leads.Technical services discussed that rv oversensing will inhibit both channels.Both leads were tested through the pacing system analyzer (psa) and everything was fine.The device was explanted, and a new device was implanted.Lead testing was performed and there were no issues.No adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the crt-d was performed.The device was confirmed to be in safety core.Review of stored memory verified that the device experienced three system faults during the time electrocautery was being used; they were three oscillator mismatch faults.These faults caused the device to go into safety core.The device was then removed from safety core status and a comprehensive series of automated diagnostic tests were conducted to verify the performance of device memory, pacing, defibrillation and recording functions.The device performed as expected for each test.Of note, energen devices have been specifically designed such that if three system resets occur within a timeframe of approximately 48 hours, the device will enter safety core.The behavior of this crt-d is consistent with devices that have reverted to safety core due to faults occurring as a result of exposure to electrocautery.

• Brand Name: ENERGEN CRT-D
• Common Device Name: IMPLANTABLE DEVICE
• 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: 20580742
• Report Number: 2124215-2024-68504
• Device Sequence Number: 15477659
• Product Code: LWP
• UDI-Device Identifier: 00802526480966
• UDI-Public: 00802526480966
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/31/2024

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: 01/24/2015
• Device Model Number: N141
• Device Catalogue Number: N141
• Device Lot Number: 107163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2013
• 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
• Patient Age: 69 YR
• Patient Sex: Male