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

Model Number G447

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/11/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was interrogated and discovered to be operating in safety mode.Additional information provided from the field indicated surgical intervention was later performed and the crt-d was explanted and replaced.No additional adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was interrogated and discovered to be operating in safety mode.Additional information provided from the field indicated surgical intervention was later performed and the crt-d was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this crt-d was thoroughly inspected and analyzed.Visual inspection of the case noted no anomalies; however, both the lv and rv set screws were noted to be missing.A memory dump noted the device came back operating in safety mode.Review of device memory suggested the device was put in communication sessions for multiple days with a programmer after it had been explanted thus causing the device to go into safety mode.The crt-d was put back into primary operation and interrogated with a programmer over a three-day period during analysis, which was able to successfully recreate this observation.The device was again put back into primary operation and sent for returned product testing with replacement set screws for both the lv and rv barrels.The crt-d was put through and passed all testing verifying nominal function commensurate with battery voltage.Analysis confirmed the safety mode observation was induced in the field and the device was operating as intended based on it programmed parameters.

• 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: 17774248
• MDR Text Key: 323736715
• Report Number: 2124215-2023-51123
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/06/2022
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 240572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention