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

Model Number G156

Device Problems Pacing Problem (1439); Unexpected Therapeutic Results (1631)

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

Event Date 03/18/2020

Event Type  Injury  

Manufacturer Narrative

No further information is available at this time.This report will be updated should further information become available.

Event Description

It was reported that this device exhibited pacing inhibition as the patient had a polypmorphic ventricular tachycardia and torsade.Technical services discussed programming changes.As therapy was inhibited, this patient was externally shocked.The rate cut off was recommended to be shortened.This device will continue to be monitored and remains in service.No additional 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: 10013536
• MDR Text Key: 189465071
• Report Number: 2124215-2020-09528
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/12/2019
• Device Model Number: G156
• Device Catalogue Number: G156
• Device Lot Number: 377405
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 04/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2017
• 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; Life Threatening; Required Intervention
• Patient Age: 58 YR