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

Model Number	N140
Medical Device Problem Codes	High impedance (1291); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) system heard beeping tones from the device.Battery longevity is at eight months.Technical services (ts) reviewed device data and found the left ventricular (lv) lead exhibited high out-of-range pacing impedance measurements measuring greater than 2,000 ohms back in may.Ts recommended checking the device and clearing the tones.At this time, the device and non-boston scientific lv lead remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) system heard beeping tones from the device.Battery longevity is at eight months.Technical services (ts) reviewed device data and found the left ventricular (lv) lead exhibited high out-of-range pacing impedance measurements measuring greater than 2,000 ohms back in may.Ts recommended checking the device and clearing the tones.At this time, the device and non-boston scientific lv lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent fluctuations in impedance measurements with no conclusive evidence of a product performance issue; please refer to the description for more information regarding the specific circumstances of this event.
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) system heard beeping tones from the device.Battery longevity is at eight months.Technical services (ts) reviewed device data and found the left ventricular (lv) lead exhibited high out-of-range pacing impedance measurements measuring greater than 2,000 ohms back in may.Ts recommended checking the device and clearing the tones.At this time, the device and non-boston scientific lv lead remains in service.No adverse patient effects were reported.This supplemental report is being filed as additional information was received which reported that this cardiac resynchronization therapy defibrillator (crt-d) system was explanted and replaced, and the non-boston scientific left ventricular (lv) lead was surgically abandoned.It was noted that the lv had abrupt changes in pacing lead impedances.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing and sensing functions were tested.Impedance testing was completed, and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.This device passed all returned product testing; however, boston scientific has initiated an investigation into the behavior described in the event description, including consideration of potential design enhancements, as deemed appropriate.
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) system heard beeping tones from the device.Battery longevity is at eight months.Technical services (ts) reviewed device data and found the left ventricular (lv) lead exhibited high out-of-range pacing impedance measurements measuring greater than 2,000 ohms back in may.Ts recommended checking the device and clearing the tones.At this time, the device and non-boston scientific lv lead remains in service.No adverse patient effects were reported.This supplemental report is being filed as additional information was received which reported that this cardiac resynchronization therapy defibrillator (crt-d) system was explanted and replaced, and the non-boston scientific left ventricular (lv) lead was surgically abandoned.It was noted that the lv had abrupt changes in pacing lead impedances.No additional adverse patient effects were reported.

• 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: 20211844
• Report Number: 2124215-2024-57293
• Device Sequence Number: 7327898
• Product Code: LWP
• UDI-Device Identifier: 00802526480959
• UDI-Public: 00802526480959
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• 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 Assistant
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/26/2025

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: 11/14/2015
• Device Model Number: N140
• Device Catalogue Number: N140
• Device Lot Number: 112558
• 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: 08/23/2024
• Supplement Date Received by Manufacturer: 10/04/2024; 10/10/2024; 03/26/2025
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 10/07/2024; 10/15/2024; 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2013
• 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: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female