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

Model Number	E143
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Under-Sensing (1661); Low impedance (2285); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited noisy signals and pacing impedance measurements low out of range on the right atrial (ra) lead.Technical services (ts) was consulted and provided troubleshooting efforts.This device remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information was added to the following fields: b5: describe event or problem field section f.For use by uf/importer.If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited noisy signals and pacing impedance measurements low out of range on the right atrial (ra) lead.Technical services (ts) was consulted and provided troubleshooting efforts.This device remains in service.No adverse patient effects were reported.Additional information was received from the field stating beeping tones were heard due to the out of range alert for pacing impedance measurements.It was also noted that there was noise oversensing followed by undersensing of a p wave signal.Ts provided new troubleshooting options for these issues.No adverse patient effects were reported.

• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 23073228
• Report Number: 2124215-2025-65276
• Device Sequence Number: 9996693
• Product Code: LWP
• UDI-Device Identifier: 00802526480744
• UDI-Public: (01)00802526480744(17)150614
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 12/16/2025

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: 06/14/2015
• Device Model Number: E143
• Device Catalogue Number: E143
• Device Lot Number: 108312
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 12/16/2025
• Date Device Manufactured: 06/19/2013
• 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
• Patient Age: 68 YR
• Patient Sex: Male