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

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	09/20/2024
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 7 months.A request was made to have data from this device analyzed.Data analysis confirmed low voltage fault was triggered and that the device power consumption was increasing in a gradual fashion.Furthermore, device replacement was recommended.This device remains in service.No adverse patient effects were reported.

• 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 ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 20629723
• Report Number: 2124215-2024-70093
• Device Sequence Number: 7327743
• Product Code: LWP
• UDI-Device Identifier: 00802526480768
• UDI-Public: 00802526480768
• 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: 2014
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/07/2024

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: 10/21/2015
• Device Model Number: E161
• Device Catalogue Number: E161
• Device Lot Number: 104851
• 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: 10/08/2024
• Initial Report FDA Received Date: 11/07/2024
• Date Device Manufactured: 10/29/2013
• 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: Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male