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

Model Number G158

Device Problem Unexpected Therapeutic Results (1631)

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

Event Date 04/08/2019

Event Type  malfunction  

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 this patient with a cardiac resynchronization therapy defibrillator (crt-d) felt that the heart rhythm was going crazy.The patient stated that something is not right with the implanted device.Additional information obtained from the field which indicated that the device went off.Reprogramming changes done to address the issue.The device remains in service.No adverse patient effects reported.

• 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 CLONMEL LIMITED; cashel road; ,; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8872189
• MDR Text Key: 153677386
• Report Number: 2124215-2019-17103
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/25/2018
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 146294
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR