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

Model Number G154

Device Problem Material Integrity Problem (2978)

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

Event Date 02/16/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system had exhibited loss of capture on the left ventricular (lv) lead.Additionally, the right ventricular (rv) lead exhibited high pacing impedance measurements and high threshold with intermittent capture.Subsequently, a revision procedure was performed.During the explant of the device, when the device was being removed from the pocket it was noted the lv lead was fractured at the header.The device was explanted and replaced, and the lv and rv lead were surgically abandoned.The device and the broken lead will be sent back for device analysis.No additional adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system had exhibited loss of capture on the left ventricular (lv) lead.Additionally, the right ventricular (rv) lead exhibited high pacing impedance measurements and high threshold with intermittent capture.Subsequently, a revision procedure was performed.During the explant of the device, when the device was being removed from the pocket it was noted the lv lead was fractured at the header.The device was explanted and replaced, and the lv and rv lead were surgically abandoned.The device and the broken lead will be sent back for device analysis.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

• Brand Name: DYNAGEN CRT-D
• Type of Device: IMPLANTABLE DEVICE
• 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: 16427971
• MDR Text Key: 310066330
• Report Number: 2124215-2023-08455
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534652
• UDI-Public: 00802526534652
• 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: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/15/2021
• Device Model Number: G154
• Device Catalogue Number: G154
• Device Lot Number: 104592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2019
• 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: 61 YR
• Patient Sex: Male