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

Model Number G156

Device Problems High impedance (1291); High Capture Threshold (3266)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that this system exhibited an out of range pacing impedance measurement greater than 3000 ohms on the right ventricular channel.A review of the stored data identified a small impedance increase over the past few months.System evaluation during a programmer session produced a threshold issue and the out of range measurement was confirmed.A boston scientific technical services consultant discussed the clinical observations with the caller.The patient will continue to be monitored.No adverse patient effect 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
• 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: 11212148
• MDR Text Key: 228162816
• Report Number: 2124215-2021-01251
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534669
• UDI-Public: 00802526534669
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/20/2020
• Device Model Number: G156
• Device Catalogue Number: G156
• Device Lot Number: 379489
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR