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

Model Number G447

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

Patient Problems Bacterial Infection (1735); Hematoma (1884); Unspecified Infection (1930)

Event Date 02/14/2024

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) had exhibited a possible infection.In addition, there was formation of blood in the pocket.A revision was performed, and the cardiac resynchronization therapy defibrillator (crt-d) was explanted.The right atrial (ra) lead, right ventricular (rv) lead and left ventricular (lv) lead remained in service.The pocket had been cleansed after blood had formed inside.No additional adverse patient effects were reported.The crt-d will not be returned.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) had exhibited a possible infection.In addition, there was formation of blood in the pocket.A revision was performed, and the cardiac resynchronization therapy defibrillator (crt-d) was explanted.The right atrial (ra) lead, right ventricular (rv) lead and left ventricular (lv) lead remained in service.The pocket had been cleansed after blood had formed inside.No additional adverse patient effects were reported.The crt-d will not be returned.Additional information received indicated that staphylococci were detected as a result of blood culture in the pocket.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.Revision to the initial emdr in blocks h5 event description and h6 patient codes.

• Brand Name: RESONATE 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: 18787313
• MDR Text Key: 336291884
• Report Number: 2124215-2024-11530
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 307606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male