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

Model Number E163

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Staphylococcus Aureus (2058)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that this device was explanted, including the right ventricular (rv) lead due to infection (staphylococcus aureus).No additional adverse patient effects were reported.

Event Description

It was reported that this device was explanted, including the right ventricular (rv) lead due to infection (staphylococcus aureus).No additional adverse patient effects were reported.This device was received by bsc.

Manufacturer Narrative

The baseline testing completed on the device found no anomalies.All testing completed on the device passed or was not applicable, therefore no problem was detected.

• Brand Name: INCEPTA ICD
• Type of Device: 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: 11105400
• MDR Text Key: 224746875
• Report Number: 2124215-2020-26486
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526480782
• UDI-Public: 00802526480782
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P960040/S235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/27/2016
• Device Model Number: E163
• Device Catalogue Number: E163
• Device Lot Number: 107660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 89 YR
• Patient Sex: Male