MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INCEPTA CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Model Number	N160
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	06/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.The baseline testing completed on the device found no failing conditions.All testing that was completed on the device passed or was not applicable, therefore no problem was detected.
Event or Problem Description
It was reported that the battery of this cardiac resynchronization therapy defibrillator (crt-d) went from 1 year of longevity remaining to elective replacement indicator (eri) status in a span of four months.Additionally, charge times were noted to have increased.Further information was received that this device was explanted and replaced.No additional adverse patient effects were reported.This device has been received for analysis.
Event or Problem Description
It was reported that the battery of this cardiac resynchronization therapy defibrillator (crt-d) went from 1 year of longevity remaining to elective replacement indicator (eri) status in a span of four months.Additionally, charge times were noted to have increased.Further information was received that this device was explanted and replaced.No additional adverse patient effects were reported.This device has been received for analysis.
Event or Problem Description
It was reported that the battery of this cardiac resynchronization therapy defibrillator (crt-d) went from 1 year of longevity remaining to elective replacement indicator (eri) status in a span of four months.Additionally, charge times were noted to have increased.No adverse patient effects were reported.At this time, this device remains in service.

• Brand Name: INCEPTA CRT-D
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY 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: 19705556
• Report Number: 2124215-2024-42300
• Device Sequence Number: 17069126
• Product Code: LWP
• UDI-Device Identifier: 00802526480997
• UDI-Public: 00802526480997
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2024
• 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): 09/05/2024

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: 04/15/2015
• Device Model Number: N160
• Device Catalogue Number: N160
• Device Lot Number: 898290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 07/23/2024; 08/30/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/06/2024; 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2013
• 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: Female