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

Model Number G156

Device Problem Defective Device (2588)

Patient Problem Death (1802)

Event Date 05/17/2020

Event Type  Death  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that the patient implanted with this cardiac resynchronization therapy defibrillator (crt-d) expired approximate two months post implant.A patient advocate expressed concern regarding device functionality at the time the patient expired and inquired about having the device interrogated.The local area field representative was contact for additional information.Neither the representative nor the following clinic were contact to interrogate the device and no further information was available.

• 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: 10265889
• MDR Text Key: 198573461
• Report Number: 2124215-2020-13960
• 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: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/08/2021
• Device Model Number: G156
• Device Catalogue Number: G156
• Device Lot Number: 381984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2019
• 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): Death
• Patient Age: 83 YR