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

Model Number G156

Device Problems High impedance (1291); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was explanted due to exhibiting high out of range pacing impedance measurements on the right ventricular channel.During the new implant procedure, a header connection issue was observed with the new lead.Another device was implanted.No additional adverse patient effects were reported.

Manufacturer Narrative

Additional information was added to the following fields: b5: describe event or problem field.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was explanted due to exhibiting high out of range pacing impedance measurements on the right ventricular (rv) channel.Initially only the rv was going to be explanted however, during the new implant procedure, a header connection issue was observed with the new lead, therefore, it was decided to replace the device as well.Another device was implanted instead.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.Pacing and sensing functions were tested and the device was verified to operate as expected.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.Additional information was added to the following fields: b5: describe event or problem field.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was explanted due to exhibiting high out of range pacing impedance measurements on the right ventricular (rv) channel.Initially only the rv was going to be explanted however, during the new implant procedure, a header connection issue was observed with the new lead, therefore, it was decided to replace the device as well.Another device was implanted instead.This device was returned to boston scientific for analysis.No additional 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: 16366035
• MDR Text Key: 309427874
• Report Number: 2124215-2023-06342
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/21/2019
• Device Model Number: G156
• Device Catalogue Number: G156
• Device Lot Number: 379130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2018
• 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): Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male