MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENERGEN? ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

Model Number	E143
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081); High impedance (1291); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the right atrial (ra) lead channel of this implantable cardioverter defibrillator (icd) has shown notable changes.Ra noise and low impedances were noted on the ra channel dating back to 2022.In early april, this patient experienced a car accident.Since the accident, the impedances have now been increasing, and no capture has been noted on the atrial channel.Technical services (ts) reviewed device data and suspects lead insulation damage and fracture.Additional information was requested from the field.This investigation will be updated when further information becomes available.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Additional Manufacturer Narrative
Further information was received, no loss of capture was found, but rather the nonbsc atrial channel had previously been programmed off.At this time, boston scientific does not consider the observation of pacing impedances within range and noise as seen on this device to be a reportable event.This investigation will be updated should further information become available.
Event or Problem Description
It was reported that the right atrial (ra) lead channel of this implantable cardioverter defibrillator (icd) has shown notable changes.Ra noise and low impedances were noted on the ra channel dating back to 2022.In early april, this patient experienced a car accident.Since the accident, the impedances have now been increasing, and no capture has been noted on the atrial channel.Technical services (ts) reviewed device data and suspects lead insulation damage and fracture.Additional information was requested from the field.This investigation will be updated when further information becomes available.Additional information was received from the field via gfe that the atrial channel was programmed off, and there was no loss of capture.The observed low impedances are a lead specific issue.No adverse patient effects were reported.
Event or Problem Description
It was reported that the right atrial (ra) lead channel of this implantable cardioverter defibrillator (icd) has shown notable changes.Ra noise and low impedances were noted on the ra channel dating back to 2022.In early april, this patient experienced a car accident.Since the accident, the impedances have now been increasing, and no capture has been noted on the atrial channel.Technical services (ts) reviewed device data and suspects lead insulation damage and fracture.Additional information was requested from the field.This investigation will be updated when further information becomes available.Additional information was received from the field via gfe that the atrial channel was programmed off, and there was no loss of capture.The observed low impedances are a lead specific issue.No adverse patient effects were reported.
Additional Manufacturer Narrative
Further information was received, no loss of capture was found, but rather the nonbsc atrial channel had previously been programmed off.At this time, boston scientific does not consider the observation of pacing impedances within range and noise as seen on this device to be a reportable event.This investigation will be updated should further information become available.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.

• Brand Name: ENERGEN? ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
• 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: 22075100
• Report Number: 2124215-2025-33317
• Device Sequence Number: 12939424
• Product Code: LWP
• UDI-Device Identifier: 00802526480744
• UDI-Public: (01)00802526480744(17)150821
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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,Followup,Followup
• Report Date (Section B): 06/23/2025

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: 08/21/2015
• Device Model Number: E143
• Device Catalogue Number: E143
• Device Lot Number: 109201
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 05/16/2025; 06/18/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 06/04/2025; 06/23/2025
• Date Device Manufactured: 08/24/2013
• 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: 63 YR
• Patient Sex: Female