MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INCEPTA? ICD; implantable cardioverter defibrillator

Model Number	E162
Medical Device Problem Codes	Premature Discharge of Battery (1057); Delayed Charge Time (2586); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) was suspected of premature battery depletion (pbd) as the battery has depleted from 7 months down to reaching elective replacement indicator state.The boston scientific technical services consultant evaluated the transmission data which demonstrated a charge time of 15.7 seconds, representing a secondary criterion for recommending a device replacement while the system continues to operate normally.Subsequently, this icd was explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.

• Brand Name: INCEPTA? ICD
• Common Device Name: implantable cardioverter defibrillator
• 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: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50313817
• Report Number: 2124215-2026-44520
• Device Sequence Number: 9982819
• Product Code: LWP
• UDI-Device Identifier: 00802526480775
• UDI-Public: (01)00802526480775(17)160821
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2026

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: 08/21/2016
• Device Model Number: E162
• Device Catalogue Number: E162
• Device Lot Number: 113311
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided; 09/28/2026
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 09/03/2026; 09/29/2026
• Date Device Manufactured: 08/28/2014
• 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: 84 YR
• Patient Sex: Male