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

Model Number G158

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

Patient Problem Asystole (4442)

Event Date 05/14/2023

Event Type  Injury  

Event Description

It was reported that, during an unrelated procedure, this cardiac resynchronization therapy defibrillator (crt-d) exhibited noise, oversensing and pacing inhibition for several seconds due to electromagnetic interference (emi).The source was turned off and the issue was resolved.This device remains in service.No further adverse patient effects were reported.

Manufacturer Narrative

Information was corrected from the following fields: h6: impact codes.

Event Description

It was reported that, during an unrelated procedure, this cardiac resynchronization therapy defibrillator (crt-d) exhibited noise, oversensing and pacing inhibition for several seconds due to electromagnetic interference (emi).The source was turned off and the issue was resolved.This device remains in service.No further adverse patient effects were reported.

• Brand Name: DYNAGEN X4 CRT-D
• Type of Device: IMPLANTABLE 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: 17066258
• MDR Text Key: 316571705
• Report Number: 2124215-2023-28553
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/23/2021
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 223560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2023
• Initial Date FDA Received: 06/05/2023
• Supplement Dates Manufacturer Received: 07/05/2023
• Supplement Dates FDA Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2019
• 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): Life Threatening; Other
• Patient Age: 69 YR
• Patient Sex: Male