MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INCEPTA? ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

Model Number	E162
Medical Device Problem Codes	High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a clinic visit, the health care professional (hcp) called technical services (ts) for further review of this implantable cardioverter defibrillator (icd) stored episodes.Upon review the presenting electrogram (egm) showed that the patient was in a ventricular fibrillation (vf) episode.The device delivered a shock, however, during the shock delivery, code 1005 which indicated an open circuit condition was recorded.The cause of the code 1005 was determined to be due to high out of range shock impedances on the right ventricular (rv) lead were recorded during the shock delivery.The shock was able to successfully convert the arrhythmia.Ts recommended for the replacement of the device and rv lead.At this time, the icd and rv lead remain in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This device was not returned for analysis.The allegation(s) in this complaint have not been confirmed as there was not enough information provided in the complaint and the product has not been returned for analysis.The "cause not established" conclusion code was selected because the reason for the alleged observation(s) could not be determined.
Event or Problem Description
It was reported that during a clinic visit, the health care professional (hcp) called technical services (ts) for further review of this implantable cardioverter defibrillator (icd) stored episodes.Upon review the presenting electrogram (egm) showed that the patient was in a ventricular fibrillation (vf) episode.The device delivered a shock, however, during the shock delivery, code 1005 which indicated an open circuit condition was recorded.The cause of the code 1005 was determined to be due to high out of range shock impedances on the right ventricular (rv) lead were recorded during the shock delivery.The shock was able to successfully convert the arrhythmia.Ts recommended for the replacement of the device and rv lead.At this time, the icd and rv lead remain in service.No additional adverse patient effects were reported.Subsequently, additional information was received that reported that the patient with this implantable cardioverter defibrillator (icd) underwent a replacement procedure, where this icd device was explanted and replaced with a new device successfully.No additional adverse patient effects were reported.

• Brand Name: INCEPTA? ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
• 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: 23053285
• Report Number: 2124215-2025-64605
• Device Sequence Number: 8685438
• Product Code: LWP
• UDI-Device Identifier: 00802526480775
• UDI-Public: (01)00802526480775(17)161107
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 12/03/2025

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: 11/07/2016
• Device Model Number: E162
• Device Catalogue Number: E162
• Device Lot Number: 114659
• 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: 08/25/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 12/03/2025
• Date Device Manufactured: 11/18/2014
• 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: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male