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

Model Number	N140
Medical Device Problem Codes	Connection Problem (2900); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a routine generator replacement procedure, this cardiac resynchronization therapy defibrillator (crt-d) was observed to have setscrew damage.The physician reported experiencing difficulties disconnecting the old left ventricular (lv) lead.Further inspection of the crt-d device showed set screw damage.The physician decided to surgically abandon the lv lead and explanted the crt-d device.The lv lead and the crt-d were successfully replaced with new a lead and device.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the device was exposed to simulated heart load conditions, and the defibrillation, pacing and sensing functions were tested.The device operated appropriately, according to its performance specifications with no interruptions in therapy output or programmer communication at the returned programmed settings.Visual inspection of the header revealed minor damage to the left ventricular distal seal plug likely due to the explant procedure.Further inspection of the header found body fluid contamination in the left ventricular distal seal plug and corresponding set screw.Analysis concluded the damaged seal plugs were likely due to the explant procedure and that the body fluid contamination entered into the header through the damaged seal plugs.
Event or Problem Description
It was reported that during a routine generator replacement procedure, this cardiac resynchronization therapy defibrillator (crt-d) was observed to have setscrew damage.The physician reported experiencing difficulties disconnecting the old left ventricular (lv) lead.Further inspection of the crt-d device showed set screw damage.The physician decided to surgically abandon the lv lead and explanted the crt-d device.The lv lead and the crt-d were successfully replaced with new a lead and device.No additional 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: 19960891
• Report Number: 2124215-2024-49883
• Device Sequence Number: 20599061
• Product Code: LWP
• UDI-Device Identifier: 00802526480959
• UDI-Public: 00802526480959
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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: 07/22/2016
• Device Model Number: N140
• Device Catalogue Number: N140
• Device Lot Number: 114905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2014
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male