MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INCEPTA ICD; Implantable Pulse Generator, Pacemaker (Non-Crt)

Model Number	E161
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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) recorded a code 1003, which states that the voltage is too low for projected remaining capacity.It was reported that a request was made to have data from this device analyzed.Data analysis showed the code 1003 was triggered inappropriately and there was no indication of that the battery was depleting more quickly than expected.However the code would remain until device changeout, with a normal 90-day changeout once elective replacement indicator (eri) was triggered.This icd remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding event cause and resolution.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) recorded a code 1003, which states that the voltage is too low for projected remaining capacity.It was reported that a request was made to have data from this device analyzed.Data analysis showed the code 1003 was triggered inappropriately and there was no indication of that the battery was depleting more quickly than expected.However the code would remain until device changeout, with a normal 90-day changeout once elective replacement indicator (eri) was triggered.This icd remains in service.No adverse patient effects were reported.

• Brand Name: INCEPTA ICD
• Common Device Name: Implantable Pulse Generator, Pacemaker (Non-Crt)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel E91 T 862; EI E91 T862
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 23703840
• Report Number: 2124215-2025-88712
• Device Sequence Number: 10691595
• Product Code: LWP
• UDI-Device Identifier: 00802526480768
• UDI-Public: (01)00802526480768(17)130915
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/14/2026

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: 09/15/2013
• Device Model Number: E161
• Device Catalogue Number: E161
• Device Lot Number: 102241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 03/23/2026; 05/07/2026; 07/28/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 04/21/2026; 05/13/2026; 08/16/2026
• Date Device Manufactured: 03/21/2012
• 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: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male