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

Model Number	N141
Medical Device Problem Codes	Premature Discharge of Battery (1057); Delayed Charge Time (2586); Battery Problem (2885)
Health Effect - Clinical Codes	Loss of consciousness (2418); Syncope/Fainting (4411)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was explanted due to concerns of premature battery depletion (pbd) as it decreased from 1 year remaining to end of life (eol) in a 7 months time period.The patient experienced two syncopal episodes during this time.A device changeout procedure was performed and it was explanted and replaced.No additional adverse patient effects were reported.It is expected to receive this product for analysis.
Additional Manufacturer Narrative
The returned cardiac resynchronization therapy defibrillator (crt-d) was analyzed and an engineering-level longevity prediction calculation was completed to assess the rate of battery depletion.Given the programmed parameters and other data stored within the memory of the device, the results of this calculation indicated that the actual rate of battery depletion fell within an acceptable range.Next, a series of diagnostic tests were conducted that verified the performance of pacing, sensing, defibrillation, and recording functions.Having met the engineering longevity prediction, functionally passed all returned product testing, and with no further information to indicate a product performance issue, we have concluded that this device experienced normal battery depletion.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was explanted due to concerns of premature battery depletion (pbd) as it decreased from 1 year remaining to end of life (eol) in a 7 months time period.The patient experienced two syncopal episodes during this time.A device changeout procedure was performed and it was explanted and replaced.No additional adverse patient effects were reported.This device has been received for analysis.

• Brand Name: ENERGEN CRT-D
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• 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: 20810855
• Report Number: 2124215-2024-75490
• Device Sequence Number: 18627280
• Product Code: LWP
• UDI-Device Identifier: 00802526480966
• UDI-Public: 00802526480966
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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: 12/17/2015
• Device Model Number: N141
• Device Catalogue Number: N141
• Device Lot Number: 112599
• 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: 11/07/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 11/29/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2013
• 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: 70 YR
• Patient Sex: Male