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

Model Number G156

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885)

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

Event Date 07/18/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis validated low voltage fault and confirmed that the power consumption was increasing in a gradual fashion.This appears consistent with capacitor degradation due to hydrogen gas content in the sealed pg atmosphere.Device replacement or reassessment was recommended.Additional information from the field representative indicated that the patient will be brought back to the office within the next couple of weeks to determine dependency and revision will be scheduled.To date, the device remains in service.No adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis validated low voltage fault and confirmed that the power consumption was increasing in a gradual fashion.This appears consistent with capacitor degradation due to hydrogen gas content in the sealed pg atmosphere.Device replacement or reassessment was recommended.Additional information from the field representative indicated that the patient will be brought back to the office within the next couple of weeks to determine dependency and revision will be scheduled.To date, the device remains in service.No adverse patient effects were reported.Additional information indicated that the device was surgically explanted and a new device was placed.No additional adverse patient effects 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: 17422431
• MDR Text Key: 320025632
• Report Number: 2124215-2023-40308
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/14/2020
• Device Model Number: G156
• Device Catalogue Number: G156
• Device Lot Number: 379603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male