MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INCEPTA CRT-D; IMPLANTABLE DEFIBRILLATOR

Model Number	N164
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited noise on the right atrial channel.Further evaluation of the patient was discussed.This device remains in service.No further adverse patient effects were reported.Additional information was received detailing that this device was explanted and replaced.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited noise on the right atrial channel.Further evaluation of the patient was discussed.This device remains in service.No further adverse patient effects were reported.Additional information was received detailing that this device was explanted and replaced.This device was returned to boston scientific for analysis.
Additional Manufacturer Narrative
The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.Pacing and sensing functions were tested and the device was verified to operate as expected.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.Additional information was added to the following fields: e1: initial reporter title e1: initial reporter first name e1: initial reporter last name e1: initial reporter facility name e1: initial reporter address 1 e1: initial reporter city e1: initial reporter state e1: initial reporter zip/post code e1: initial reporter phone e2: health professional? e3: occupation g2: report source.

• Brand Name: INCEPTA CRT-D
• Common Device Name: IMPLANTABLE 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: 16980011
• Report Number: 2124215-2023-25479
• Device Sequence Number: 15073119
• Product Code: LWP
• UDI-Device Identifier: 00802526481031
• UDI-Public: 00802526481031
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 07/18/2023

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: 02/13/2016
• Device Model Number: N164
• Device Catalogue Number: N164
• Device Lot Number: 105587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2014
• 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: 72 YR
• Patient Sex: Female