MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G158

Device Problems Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Therapeutic Results (1631)

Patient Problem Electric Shock (2554)

Event Date 11/21/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) delivered 6 inappropriate shocks and bursts of anti tachycardia pacing (atp) due to suspected atrial driven rhythms.Sustained rate duration (srd) feature timed out and did not inhibit inappropriate therapy.The episode was isolated but therapy was exhausted.Boston scientific technical services reviewed episode and recommended further review with physician.Therapy delivery is considered inappropriate as this device is not intended to treat atrial arrhythmias.This device remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

This supplemental report was filled to correct field h6: "device codes.".

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) delivered 6 inappropriate shocks and bursts of anti tachycardia pacing (atp) due to suspected atrial driven rhythms.Sustained rate duration (srd) feature timed out and did not inhibit inappropriate therapy.The episode was isolated but therapy was exhausted.Boston scientific technical services reviewed episode and recommended further review with physician.Attempts to obtain more information on this case were unsuccessful.Therapy delivery is considered inappropriate as this device is not intended to treat atrial arrhythmias.This device remains in service.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN X4 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
• MDR Report Key: 11136445
• MDR Text Key: 225755613
• Report Number: 2124215-2020-27727
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534904
• UDI-Public: 00802526534904
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/05/2019
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 168804
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2020
• Patient Sequence Number: 1
• Patient Age: 64 YR