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

Model Number G158

Device Problem Pocket Stimulation (1463)

Patient Problems Device Overstimulation of Tissue (1991); Burning Sensation (2146); Pericardial Effusion (3271)

Event Date 10/02/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this patient with a cardiac resynchronization therapy defibrillator (crt-d) was diagnosed with pericardial effusion and was feeling a burning sensation at the device site.The patient was also feeling extra cardiac stimulation.Further, procedure was done to drain the fluid.The patient was also told that one of the leads perforated patient's heart.To date, this device remains in service.No additional adverse patient effects 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
• 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: 17989983
• MDR Text Key: 326323977
• Report Number: 2124215-2023-58800
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/25/2022
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 240156
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2020
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male