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

Model Number G158

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

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 12/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product has been received for analysis.This report will be updated upon completion of analysis, should pertinent information be provided.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was explanted as part of a whole system explant due to infection.The patient was hospitalized due to an un-related event when lead vegetation became evident.A new system was implanted a week later.No additional adverse patient effects where reported.

Manufacturer Narrative

Analysis of the returned product is not able to provide relevant information for infection-related allegations.There is no indication the device manufacturing process contributed to the reported complaint.No further information concerning this report is expected, our investigation is complete.

Event Description

It was reported that additional information was received from product investigation closure, a supplemental report is being filed.It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was explanted due to infection and a new system was implanted a week later.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN X4 CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11211859
• MDR Text Key: 228162935
• Report Number: 2124215-2020-28680
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534904
• UDI-Public: 00802526534904
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/06/2021
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 222043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR