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

Model Number G447

Device Problems High impedance (1291); High Capture Threshold (3266)

Patient Problems Unspecified Infection (1930); Septic Shock (2068)

Event Date 02/05/2024

Event Type  Injury  

Event Description

It was reported that during the three-month post implant check on this newly implanted cardiac resynchronization therapy defibrillator (crt-d) the patient had remained in the hospital due to septic shock.It was recently discovered that the right ventricular (rv) lead trends were increasing in both pacing impedance from 595 to 1466 ohms and threshold measurements from 0.6 to 1.2v (volts) at 0.4ms (milliseconds).The shock impedance measurements also increased from 73 to 97 ohms.Technical services (ts) was consulted due to the lead trend and the physician is considering the device be removed due to an infection.Ts advised the impedance change is most likely related to physiologic status or lead/tissue interface condition change rather than a lead issue.There was no noise noted on the stored electrograms (egms).Ts recommended further lead evaluation with isometric manipulations.At this time the crt-d and leads remain in service.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: 18712729
• MDR Text Key: 335481152
• Report Number: 2124215-2024-09045
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• 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: 318510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2023
• 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): Life Threatening; Hospitalization; Other
• Patient Age: 73 YR
• Patient Sex: Female