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

Model Number G447

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

Patient Problems Unspecified Infection (1930); Impaired Healing (2378)

Event Date 07/05/2023

Event Type  Injury  

Manufacturer Narrative

The device has been received for analysis.Upon completion of the analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) had an infection.Moreover, the post operative site was not healing and was bleeding and continues to leak.Patient was put on antibiotic for a week.Furthermore, the device was surgically explanted.No additional adverse patient effects were reported.

Manufacturer Narrative

The device has been received for analysis.Upon completion of the analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.The device was successfully interrogated and completed a memory dump.Visual inspection found no irregularities that would have been present when the customer received /utilized the device, and the header was firmly attached.The longevity calculation for this device passed or was not applicable.The infection or infection related allegation could not be confirmed by lab analysis but was assigned with known inherent risk.Infection is a known medical risk when the skin barrier is breached.Analysis of the returned product is not able to provide relevant information for infection-related allegations.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) had an infection.Moreover, the post operative site was not healing and was bleeding and continues to leak.Patient was put on antibiotic for a week.Furthermore, the device was surgically explanted.No additional adverse patient effects were reported.

• Brand Name: RESONATE 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: 17431778
• MDR Text Key: 320113448
• Report Number: 2124215-2023-40630
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589539
• UDI-Public: 00802526589539
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 284717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2022
• 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; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Race: White