MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN X4 CRT-D; IMPLANTABLE DEVICE

Model Number G156

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2020

Event Type  malfunction  

Event Description

It was reported that this patient presented to the emergency room (er).The presenting electrogram (egm) indicated that the patient was exhibiting a ventricular tachycardia (vt) rhythm.There were also stored vt episodes exhibiting a rhythm in the 115 beat per minute (bpm) to 140 bpm range, which is in the programmed antitachycardia pacing (atp) therapy-only zone of the patients implanted cardiac resynchronization therapy defibrillator (crt-d) device.Fifty-five (55) rounds of atp therapy were provided across those stored episodes.The vt rhythm was not converted by the device therapy and atp therapy was exhausted.Boston scientific technical services (ts) reviewed these reports with the er physician and indicated that further review is recommended.Ts also called and spoke to the boston scientific representative (rep) that supports the associated healthcare facility (hcf) to let them know that they spoke with the er physician.The device remains in service.No patient symptoms or adverse patient effects were reported.

• Brand Name: DYNAGEN X4 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: 10636795
• MDR Text Key: 210374094
• Report Number: 2124215-2020-19614
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/14/2018
• Device Model Number: G156
• Device Catalogue Number: G156
• Device Lot Number: 374998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR