MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G154

Device Problems Pacing Problem (1439); Inaccurate Synchronization (1609)

Patient Problem Ventricular Tachycardia (2132)

Event Date 12/23/2020

Event Type  Injury  

Event Description

It was reported that the local field representative contacted technical services (ts) and requested review of a recent ventricular tachycardia (vt) event, for which, anti-tachycardia pacing (atp) therapy was delivered and was felt to be inappropriate.Ts reviewed the event and noted the presence of three biv trigger paces that preceded the run of vt.It was suspected that biv trigger pacing may have induced the vt.Atp did not convert the rhythm, however, they rhythm self terminated after the third burst of atp.Ts then reviewed a previous stored vt event and noted a run of vt that followed a normal as/rvp/lvp sequence and noted the vt was not always preceded by biv trigger pacing.Ts discussed the option of decreasing the biv trigger maximum rate if concerned.No additional adverse patient effects were reported.This device remains in service.

• Brand Name: DYNAGEN CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• 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: 11237582
• MDR Text Key: 228915460
• Report Number: 2124215-2021-02377
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534652
• UDI-Public: 00802526534652
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/11/2019
• Device Model Number: G154
• Device Catalogue Number: G154
• Device Lot Number: 102316
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2017
• 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
• Patient Age: 79 YR