MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Model Number G247

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Failure to Read Input Signal (1581)

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

Event Date 08/02/2023

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system recorded noise on the right ventricular (rv) channel during a declared episode of pacemaker mediated tachycardia (pmt), and there were concerns of oversensing.Additionally, the device recorded out of range intrinsic rv amplitudes.Technical services (ts) reviewed the episode data and agreed that the noise had been oversensed, resulting in pacing inhibition.Further patient evaluation was recommended to determine if the cause of the noise might be myopotential.Subsequent patient testing noted that plyometrics and breathing produced small levels of noise which were not oversensed.Ts further recommended defibrillator threshold testing be performed, and provided recommendations for device reprogramming or further monitoring.Further information indicated that the physician chose to continue to monitor the patient.This device remains in service.No adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system recorded noise on the right ventricular (rv) channel during a declared episode of pacemaker mediated tachycardia (pmt), and there were concerns of oversensing.Additionally, the device recorded out of range intrinsic rv amplitudes.Technical services (ts) reviewed the episode data and agreed that the noise had been oversensed, resulting in pacing inhibition.Further patient evaluation was recommended to determine if the cause of the noise might be myopotential.Subsequent patient testing noted that plyometrics and breathing produced small levels of noise which were not oversensed.Ts further recommended defibrillator threshold testing be performed, and provided recommendations for device reprogramming or further monitoring.Further information indicated that the physician chose to continue to monitor the patient.This device remains in service.No adverse patient effects were reported.Information was later received that this crt-d oversensed far field r waves on the right atrial (ra) channel, leading to inappropriate mode switching to atrial tachy response (atr).Additionally further pmt episodes were recorded.Ts reviewed the pmt episodes and noted that they appeared to be a result of sinus tachycardia and not true pmt.Device reprogramming options were discussed.No patient symptoms were reported as a result of the oversensing.

• Brand Name: VIGILANT X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• 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: 17560117
• MDR Text Key: 321290092
• Report Number: 2124215-2023-43980
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589287
• UDI-Public: 00802526589287
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/08/2021
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 227016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2019
• 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 Age: 68 YR
• Patient Sex: Male