MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INCEPTA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number E161

Device Problems Pacing Problem (1439); Unexpected Therapeutic Results (1631)

Patient Problems Cardiac Arrest (1762); Electric Shock (2554)

Event Date 09/27/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) was commanded to deliver shocks twice which were unsuccessful, therefore the patient coded.The patient needed external shock.The health care professional also attempted performing a commanded anti-tachycardia pacing (atp) from the test screen but was not able due to the way in which the device is programmed.The caller was educated on how to program the icd in order to deliver atp appropriately.The icd remains in service.No additional adverse patient effects were reported.

• Brand Name: INCEPTA ICD
• Type of Device: IMPLANTABLE CARDIOVERTER 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: 15636096
• MDR Text Key: 302053374
• Report Number: 2124215-2022-42509
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526480768
• UDI-Public: 00802526480768
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/26/2016
• Device Model Number: E161
• Device Catalogue Number: E161
• Device Lot Number: 106798
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2014
• 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): Other; Required Intervention; Life Threatening
• Patient Age: 72 YR
• Patient Sex: Male