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

Model Number G158

Device Problems Failure to Capture (1081); High Capture Threshold (3266)

Patient Problems Syncope/Fainting (4411); Asystole (4442)

Event Date 01/08/2023

Event Type  Injury  

Event Description

It was reported that this patient presented to the hospital for asystole and syncope.Upon interrogation of this cardiac resynchronization therapy defibrillator (crt-d) it was found that there was loss of capture (loc) on the left ventricular (lv) lead as well as high capture thresholds on the right ventricular (rv) lead.Technical services (ts) analyzed presenting electrogram (egm) and discussed reprogramming options with boston scientific field sales representative.The lv lead is a non-boston scientific product.Threshold outputs were increased by programming.No additional adverse patient effects were reported.Currently, this crt-d system remains in service.

Event Description

It was reported that this patient presented to the hospital for asystole and syncope.Upon interrogation of this cardiac resynchronization therapy defibrillator (crt-d) it was found that there was loss of capture (loc) on the left ventricular (lv) lead as well as high capture thresholds on the right ventricular (rv) lead.Technical services (ts) analyzed presenting electrogram (egm) and discussed reprogramming options with boston scientific field sales representative.The lv lead is a non-boston scientific product.Threshold outputs were increased by programming.No additional adverse patient effects were reported.Currently, this crt-d system remains in service.According to additional information, this crt-d was explanted and replaced with a new device.No additional adverse patient effects were reported.As of today, this product has not been received by boston scientific for further evaluation.

• 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: 16443663
• MDR Text Key: 310250631
• Report Number: 2124215-2023-09000
• 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: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/06/2017
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 137710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2015
• 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: 67 YR
• Patient Sex: Male