MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN X4 CRT-D; CARDIAC RESYNCHRONIZATION DEFIBRILLATOR

Model Number G158

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439)

Patient Problem Asystole (4442)

Event Date 09/03/2017

Event Type  malfunction  

Event Description

It was reported that this system with a cardiac resynchronization therapy defibrillator (crt-d) and a right ventricular (rv) lead has been showing over sensed noisy signals dating back to near the time of implant.The noise looks quite non-physiologic according to the field representative.An abandoned rv lead was suspected as the cause for the noisy signals.An x ray analysis was recommended in order to determine the exact origin.The patient appears to be pacing dependent.The longest pause noted was more than two seconds.According to the field representative, no action has been taken at this time, also, the patient will be closely monitored.No x-ray analysis has been completed at this time and possible reprogramming will be completed if issues continue.The rv lead and the crt-d remain in service.No additional adverse patient effects were reported.

Manufacturer Narrative

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

• Brand Name: DYNAGEN X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION 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: 16172254
• MDR Text Key: 307836768
• Report Number: 2124215-2023-01406
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/10/2019
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 173470
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2022
• Initial Date FDA Received: 01/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2017
• 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: 87 YR
• Patient Sex: Female