MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INCEPTA CRT-D; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	N161
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/24/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system exhibited an infection.As a result, the crt-d device, the right atrial (ra) lead and the right ventricular (rv) lead were explanted.It was noted that the left ventricular (lv) lead was unable to be extracted and it will be removed when the patient undergoes an aortic valve replacement.The rv and lv leads are not boston scientific products.In addition, a new rv lead was temporarily implanted.It was subsequently reported that the patient passed away approximately eight hours after the surgical procedure due to complications.It was indicated that the extracted products will not be returned.

• Brand Name: INCEPTA CRT-D
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 17950997
• Report Number: 2124215-2023-57546
• Device Sequence Number: 6565084
• Product Code: LWP
• UDI-Device Identifier: 00802526481000
• UDI-Public: 00802526481000
• 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: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2023

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: 10/21/2016
• Device Model Number: N161
• Device Catalogue Number: N161
• Device Lot Number: 502729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2023
• Initial Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2014
• 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; Death; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male