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

Model Number	N141
Medical Device Problem Codes	Premature Discharge of Battery (1057); Delayed Charge Time (2586); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker showed a decrease in the estimated battery longevity and declared elective replacement indicator (eri), despite previously indicating 8 months of remaining life.Technical services (ts) were consulted and confirmed that eri was triggered by a charge time of 16 seconds.Additionally, a gradual increase in power consumption over the past few years was also confirmed.Ts recommended replacing the device within 90 days or sooner due to concerns about the long charge time.The device remains implanted and in service, with no reported adverse effects on the patient.
Additional Manufacturer Narrative
Additional information received indicated that the device was replaced on november 26, 2024.It was not stated whether the product would be returned.
Event or Problem Description
It was reported that this pacemaker showed a decrease in the estimated battery longevity and declared elective replacement indicator (eri), despite previously indicating 8 months of remaining life.Technical services (ts) were consulted and confirmed that eri was triggered by a charge time of 16 seconds.Additionally, a gradual increase in power consumption over the past few years was also confirmed.Ts recommended replacing the device within 90 days or sooner due to concerns about the long charge time.The device remains implanted and in service, with no reported adverse effects on the patient.Additional information received indicated that the device was replaced on november 26, 2024.It was not stated whether the product would be returned.

• 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: 20325619
• Report Number: 2124215-2024-60672
• Device Sequence Number: 15361194
• Product Code: LWP
• UDI-Device Identifier: 00802526480966
• UDI-Public: 00802526480966
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2024
• 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): 02/24/2025

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: 06/05/2015
• Device Model Number: N141
• Device Catalogue Number: N141
• Device Lot Number: 109412
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 02/24/2025
• Date Device Manufactured: 06/11/2013
• 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: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male