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

Model Number	E163
Medical Device Problem Code	Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) was unable to be interrogated.Technical services (ts) was contacted and recommended possible troubleshooting options.This icd was subsequently explanted due to normal battery depletion and successfully replaced.No adverse patient effects were reported.
Additional Manufacturer Narrative
This report is being submitted to correct the adverse event/product problem (b1), outcomes attrib to adv event (b2), and describe event or problem (b5) in section b.Adverse event/product prob; the occupation (e3) in section e.Initial reporter; and the type of reportable event (h1) and impact codes (2) (h6) in section h.Device manufacturers only.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) was unable to be interrogated.Technical services (ts) was contacted and recommended possible troubleshooting options.This icd was subsequently explanted due to normal battery depletion and successfully replaced.No adverse patient effects were reported.Additional information received detailed this icd had recorded an alert for the explant indicator approximately five months before being unable to be interrogated.Additionally, this icd had been implanted for approximately 13 years at the point of explant and remote monitoring had been disabled due to limited battery capacity.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) was unable to be interrogated.Technical services (ts) was contacted and recommended possible troubleshooting options.This icd was subsequently explanted due to normal battery depletion and successfully replaced.No adverse patient effects were reported.Additional information received detailed this icd had recorded an alert for the explant indicator approximately five months before being unable to be interrogated.Additionally, this icd had been implanted for approximately 13 years at the point of explant and remote monitoring had been disabled due to limited battery capacity.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This device was not returned for analysis; therefore, a technical analysis could not be performed.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of difficult to interrogate/telemetry (wand) 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.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.

• Brand Name: INCEPTA? ICD
• Common Device Name: IMPLANTABLE PULSE
• 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: 24205895
• Report Number: 2124215-2026-05193
• Device Sequence Number: 15916435
• Product Code: LWP
• UDI-Device Identifier: 00802526480782
• UDI-Public: (01)00802526480782(17)150904
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2026
• 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,Followup
• Report Date (Section B): 06/17/2026

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: 09/04/2015
• Device Model Number: E163
• Device Catalogue Number: E163
• Device Lot Number: 105683
• 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: 01/10/2026
• Supplement Date Received by Manufacturer: 01/28/2026; 06/16/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 01/29/2026; 06/17/2026
• Date Device Manufactured: 09/09/2013
• 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: 83 YR
• Patient Sex: Male