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

Model Number E163

Device Problem Inaccurate Synchronization (1609)

Patient Problem Ventricular Fibrillation (2130)

Event Date 08/03/2022

Event Type  Injury  

Event Description

It was reported that the self-conducted ventricular rhythm from the patient with this implantable cardioverter defibrillator (icd), accelerated from the vt zone to the vf zone after the first shock therapy was applied.The device then delivered a 41 joule shock that successfully converted the rhythm.No additional adverse patient effects were reported.This device system remains in service.

• 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: 15214132
• MDR Text Key: 297760129
• Report Number: 2124215-2022-30206
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526480782
• UDI-Public: 00802526480782
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/20/2015
• Device Model Number: E163
• Device Catalogue Number: E163
• Device Lot Number: 104245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2013
• 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): Life Threatening; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male