MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D)

Model Number G158

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Dizziness (2194); Syncope/Fainting (4411)

Event Date 09/15/2023

Event Type  Injury  

Event Description

It was reported that the patient's wife had called, stating that the patient with this cardiac resynchronization therapy defibrillator (crt-d) device received a shock few weeks ago.The patient felt lightheaded and passed out and then the device exhibited a shock.The patient was admitted to the hospital and the device was interrogated while in hospital.There were stored episodes of non-sustained ventricular tachycardia (nsvt).Boston scientific representative (bsc) stated that there was a device activity noted couple of months back and the patient was seen in emergency room (er) in (b)(6) for shock and the ventricular rate 243bpm which is normal device function noted on consult transmission.The healthcare professional stated that the device is functioning appropriately.Technical services (ts) recommended to see the physician for further discussion.This device remains in service.No adverse patient effects were reported.

• Brand Name: DYNAGEN X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (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: 17873037
• MDR Text Key: 324944107
• Report Number: 2124215-2023-54897
• 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: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/10/2021
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 224930
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2019
• 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
• Patient Age: 70 YR
• Patient Sex: Male