MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INCEPTA ICD; IMPLANTABLE PACEMAKER

Model Number	E161
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	09/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) dropped its battery longevity from 2 years to elective replacement indicator (eri) in a span of 14 months.A request was made to have data from this device analyzed.Data analysis confirmed there were no faults or resets stored within device memory.However, it was noted that the device hardware was not detecting the loss of battery energy and with this the battery status indicators are not reflecting the depletion condition and are inaccurate.Hence, the device is malfunctioning, and device replacement was recommended.Subsequently, this device was explanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the device; however the device will not be returned.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause linked to device but unable to trace more specifically.A risk review was completed and confirmed that the event of gas gauge/longevity not as expected was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) dropped its battery longevity from 2 years to elective replacement indicator (eri) in a span of 14 months.A request was made to have data from this device analyzed.Data analysis confirmed there were no faults or resets stored within device memory.However, it was noted that the device hardware was not detecting the loss of battery energy and with this the battery status indicators are not reflecting the depletion condition and are inaccurate.Hence, the device is malfunctioning, and device replacement was recommended.Subsequently, this device was explanted.No additional adverse patient effects were reported.

• Brand Name: INCEPTA ICD
• Common Device Name: IMPLANTABLE PACEMAKER
• 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: 23287789
• Report Number: 2124215-2025-72821
• Device Sequence Number: 5559922
• Product Code: LWP
• UDI-Device Identifier: 00802526480768
• UDI-Public: (01)00802526480768(17)130426
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: 04/26/2013
• Device Model Number: E161
• Device Catalogue Number: E161
• Device Lot Number: 101231
• 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: 09/16/2025
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 04/16/2026
• Date Device Manufactured: 10/28/2011
• 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: 83 YR
• Patient Sex: Female