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

Model Number G156

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Staphylococcus Aureus (2058)

Event Date 06/14/2019

Event Type  Death  

Manufacturer Narrative

No products were removed from the patient.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 the patient implanted with this product presented to the hospital with fever and other symptoms.Through blood cultures it was determined the patient had bacteremia - staph aureus.An echocardiogram was performed and vegetation was noted on the leads.The patient was referred for system extraction.The patient was placed under general anesthesia and prior to lead manipulation new onset ventricular tachycardia (vt)/ventricular fibrillation (vf) was discovered.It was believed to be associated with acute anterior wall myocardial infarction.Multiple shocks through the device and externally were delivered.The vt/vf was incessant with pulseless electrical activity through the resuscitation efforts.Subsequently, the patient expired approximately an hour later.

• 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: 8800157
• MDR Text Key: 151358481
• Report Number: 2124215-2019-13993
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/05/2018
• Device Model Number: G156
• Device Catalogue Number: G156
• Device Lot Number: 373877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR