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

Model Number E161

Device Problems Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Use of Device Problem (1670); Data Problem (3196)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 02/23/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient implanted with this implantable cardioverter defibrillator (icd) underwent an unrelated open heart surgery.A lot of ventricular episodes were stored at that time with no therapy delivered due to magnet application.However, there was one episode with a single burst of anti-tachycardia pacing (atp) on the day of the procedure, and it was suspected that the magnet slid off the device during this episode.A second episode was stored a week after the procedure due to suspected atrial fibrillation (af) with rapid ventricular response (rvr), with a single burst of atp and a 41j shock delivered.Technical services (ts) discussed troubleshooting options and programming considerations.This icd remains in service.No additional adverse patient effects were reported.

• 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: 18923756
• MDR Text Key: 337900148
• Report Number: 2124215-2024-16160
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/14/2015
• Device Model Number: E161
• Device Catalogue Number: E161
• Device Lot Number: 103819
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2013
• 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 Age: 58 YR
• Patient Sex: Male