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

Model Number G447

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2024

Event Type  malfunction  

Event Description

It was reported that the patients remote communicator displayed a red call doctor icon.Subsequently, troubleshooting was performed, and the communicator was power cycled, and a successful patient-initiated interrogation was sent.The patient was referred to contact their clinic regarding the red call doctor icon.At this time, this cardiac resynchronization therapy defibrillator (crt-d) remains in service and there were no adverse patient effects reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Please refer to b5 describe event or problem for more information regarding the specific circumstances of this event.

Event Description

It was reported that the patients remote communicator displayed a red call doctor icon.Subsequently, troubleshooting was performed, and the communicator was power cycled, and a successful patient-initiated interrogation was sent.The patient was referred to contact their clinic regarding the red call doctor icon.At this time, this cardiac resynchronization therapy defibrillator (crt-d) remains in service and there were no adverse patient effects reported.Multiple attempts were made to obtain information regarding additional information unfortunately there was no further information available.

• 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: 18828066
• MDR Text Key: 336853820
• Report Number: 2124215-2024-13032
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2023
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 265075
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1