MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Model Number G151

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438)

Patient Problems Dizziness (2194); Insufficient Information (4580)

Event Date 07/17/2023

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited noise and oversensing on the atrial channel as well as low amplitude.The involved right atrial (ra) lead is a non boston scientific product.Additionally, the patient experienced lightheadedness and felt symptomatic.A patient initiated interrogation was performed and boston scientific technical services (ts) did not observe new episodes.No adverse patient effects were reported.At this time, this device system remains in service.

• Brand Name: DYNAGEN CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• 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: 18990965
• MDR Text Key: 338898923
• Report Number: 2124215-2024-18652
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534638
• UDI-Public: 00802526534638
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/24/2022
• Device Model Number: G151
• Device Catalogue Number: G151
• Device Lot Number: 141283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2020
• 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 Age: 63 YR
• Patient Sex: Male