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

Model Number G158

Device Problems High impedance (1291); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 03/20/2024

Event Type  Injury  

Event Description

It was reported that this patient with a cardiac resynchronization therapy defibrillator (crt-d) presented to the emergency department, following multiple shock deliveries.Upon interrogation, a code 1005, indicative an open circuit condition, was observed.This alert was declared as the shock impedance was greater than 145 ohms.Additionally, it was confirmed that the patient had received a total of eight shocks, resulting in therapy exhaustion.The physician suspected that the arrhythmia was atrial in origin, with subsequent ventricular conduction, and thus the anti-tachycardia pacing (atp) and shocks that were delivered were inappropriate.Boston scientific technical services was contacted and it was discussed that calcification was possibly the cause of the gradually increasing shock impedance measurements.Right ventricular (rv) lead replacement was recommended, as therapy may not be effective with shock impedance greater than 145 ohms.Additionally, as the crt-d device was nearing end-of-life due to normal battery depletion, potential device replacement during the rv lead revision was also mentioned.At this time, the system remains implanted and in-service.The patient is currently hospitalized and intubated.

Event Description

It was reported that this patient with a cardiac resynchronization therapy defibrillator (crt-d) presented to the emergency department, following multiple shock deliveries.Upon interrogation, a code 1005, indicative an open circuit condition, was observed.This alert was declared as the shock impedance was greater than 145 ohms.Additionally, it was confirmed that the patient had received a total of eight shocks, resulting in therapy exhaustion.The physician suspected that the arrhythmia was atrial in origin, with subsequent ventricular conduction, and thus the anti-tachycardia pacing (atp) and shocks that were delivered were inappropriate.Boston scientific technical services was contacted and it was discussed that calcification was possibly the cause of the gradually increasing shock impedance measurements.Right ventricular (rv) lead replacement was recommended, as therapy may not be effective with shock impedance greater than 145 ohms.Additionally, as the crt-d device was nearing end-of-life due to normal battery depletion, potential device replacement during the rv lead revision was also mentioned.The patient is currently hospitalized and intubated.However, the sales representative recently confirmed that no surgical intervention has occurred and at this time, the system remains implanted and in-service.No further information was provided regarding the patient status.

• 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: 19144326
• MDR Text Key: 340607596
• Report Number: 2124215-2024-23928
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/13/2024

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: 04/01/2017
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 132407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 66 YR
• Patient Sex: Male