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

Model Number	N164
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	03/30/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) contracted a (b)(6) infection which traveled to the device.The patient was being prepared for a device explant when they passed away.It was noted that the patient was unable to withstand the anesthesia.The device was not removed.

• 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: 14106732
• Report Number: 2124215-2022-11159
• Device Sequence Number: 6428021
• Product Code: LWP
• UDI-Device Identifier: 00802526481031
• UDI-Public: 00802526481031
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 04/13/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/02/2016
• Device Model Number: N164
• Device Catalogue Number: N164
• Device Lot Number: 106174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2014
• 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; Death
• Patient Age: 79 YR
• Patient Sex: Male