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

Model Number	N140
Medical Device Problem Codes	Premature Discharge of Battery (1057); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the battery of this cardiac resynchronization therapy defibrillator (crt-d) was suspected to be depleting prematurely.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting normally.Technical services stated that labeled recommendations apply.Subsequently this cardiac resynchronization therapy defibrillator (crt-d) was explanted and replaced.This product has been returned for analysis.No additional advent patient effects were reported.
Event or Problem Description
It was reported that the battery of this cardiac resynchronization therapy defibrillator (crt-d) was suspected to be depleting prematurely.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting normally.Technical services stated that labeled recommendations apply.Subsequently this cardiac resynchronization therapy defibrillator (crt-d) was explanted and replaced with normal battery depletion.This product has been returned for analysis.No adverse patient effects were reported.
Additional Manufacturer Narrative
This report contains correction of b5: describe event or problem, h6: impact codes, aware date.The allegation of premature battery depletion was disproved by analysis as such no report is required for the explant.

• Brand Name: ENERGEN CRT-D
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS
• 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: 21277617
• Report Number: 2124215-2025-04887
• Device Sequence Number: 9320558
• Product Code: LWP
• UDI-Device Identifier: 00802526480959
• UDI-Public: 00802526480959
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: 2025
• 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): 01/31/2025

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: 09/16/2014
• Device Model Number: N140
• Device Catalogue Number: N140
• Device Lot Number: 105661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 01/31/2025
• Date Device Manufactured: 09/18/2012
• 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: 70 YR
• Patient Sex: Female