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

Model Number G150

Device Problems Pacing Problem (1439); Failure to Convert Rhythm (1540); Failure to Read Input Signal (1581); Under-Sensing (1661)

Patient Problem Electric Shock (2554)

Event Date 11/09/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that electrogram (egm) review was requested for this cardiac resynchronization therapy defibrillator (crt-d) system due to undersensing of ventricular flutter with inappropriate pacing.The device was programmed to vvi 80 beats per minute (bpm), and right ventricular (rv) sensitivity was programmed to 0.6mv.Technical services (ts) explained that automatic gain control (agc) is set to 8 times the sensing floor when pacing, and the signal should be visible before the next paced event.The field representative measured the signal, and it was 0.2-0.4mv.It was noted that the patient had a left ventricular assist device (lvad) implanted three months prior, and the device sensing was fine prior to lvad placement.Ts reviewed that it was not unusual for the lvad to cause amplitudes to decrease.Technical services (ts) reviewed troubleshooting options and programming considerations.Anti-tachycardia pacing (atp) did not convert the rhythm, and commanded 41j shock was delivered.This crt-d system remains in service.No additional adverse patient effects were reported.

• 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: 18263889
• MDR Text Key: 329664617
• Report Number: 2124215-2023-68600
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534614
• UDI-Public: 00802526534614
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/26/2023
• Device Model Number: G150
• Device Catalogue Number: G150
• Device Lot Number: 502154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2021
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male