MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN X4 CRT-D; IMPLANTABLE DEVICE

Model Number G158

Device Problem Failure to Convert Rhythm (1540)

Patient Problems Chest Pain (1776); Dizziness (2194); No Code Available (3191)

Event Date 06/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that this patient experienced symptoms of chest pain and dizziness and received anti-tachycardia pacing (atp) therapy and 8 total shocks from their cardiac resynchronization therapy defibrillator (crt-d) device.The shocks were noted to have successfully converted the patients atrial fibrillation (af) rhythm but the shocks failed to convert the patients ventricular tachycardia (vt) rhythm and therapy was exhausted, but the vt rhythm converted on its own.Subsequent defibrillation threshold (dft) testing was performed with the crt-d device programmed such that the upper right ventricular (rv) lead shocking coil was deactivated, leaving the other lower rv lead shocking coil active and programmed in a lead to device can configuration.During this dft testing, successful conversion was achieved with a shock of 31 joules.In addition, the patient was started on medication.The device remains in-service.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN X4 CRT-D
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CLONMEL LIMITED; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 10255163
• MDR Text Key: 198336129
• Report Number: 2124215-2020-13620
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534904
• UDI-Public: 00802526534904
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/24/2020
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 198830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2018
• 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: 72 YR