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

Model Number G156

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574); Use of Device Problem (1670); Low impedance (2285)

Patient Problem Electric Shock (2554)

Event Date 08/27/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1004 indicative of a short circuit condition, on the right ventricular (rv) lead channel.Additionally, this device recorded a low out of range impedance value on the rv channel.Technical services (ts) reviewed the device data and noted that this device had delivered two shocks, and it appeared that they had been inappropriate due to incorrect device programming.Ts advised that the patient did not have tachy therapy available due as the available information indicated the crt-d was likely damaged, and recommended replacement of both this crt-d and the associated rv lead.The treating physician was notified.This device remains in service.No additional adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1004 indicative of a short circuit condition, on the right ventricular (rv) lead channel.Additionally, this device recorded a low out of range impedance value on the rv channel.Technical services (ts) reviewed the device data and noted that this device had delivered two shocks, and it appeared that they had been inappropriate due to incorrect device programming.Ts advised that the patient did not have tachy therapy available due as the available information indicated the crt-d was likely damaged, and recommended replacement of both this crt-d and the associated rv lead.The treating physician was notified.This device was subsequently explanted and successfully replaced.No additional adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1004 indicative of a short circuit condition, on the right ventricular (rv) lead channel.Additionally, this device recorded a low out of range impedance value on the rv channel.Technical services (ts) reviewed the device data and noted that this device had delivered two shocks, and it appeared that they had been inappropriate due to incorrect device programming.Ts advised that the patient did not have tachy therapy available due as the available information indicated the crt-d was likely damaged, and recommended replacement of both this crt-d and the associated rv lead.The treating physician was notified.This device was subsequently explanted and successfully replaced.No additional adverse patient effects were reported.Information was later received that the associated rv lead was fractured.

• Brand Name: DYNAGEN X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17764181
• MDR Text Key: 323599235
• Report Number: 2124215-2023-50731
• 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,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/07/2019
• Device Model Number: G156
• Device Catalogue Number: G156
• Device Lot Number: 376175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2017
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male