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

Model Number G224

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Low impedance (2285)

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

Event Date 01/29/2024

Event Type  malfunction  

Event Description

It was reported that the cardiac resynchronization therapy defibrillator (crt-d) recorded oversensing noise in the right ventricular (rv) channel.Noise oversensing was noted when the patient would sit down on his bed, possibly due to an electrical nearby.All other measurements were stable, and noise was not able to be reproduced.Boston scientific technical services provided troubleshooting steps to rule out mechanical and lead impairment.There were no adverse patient effects reported.This device and rv lead remain in-service.

Event Description

It was reported that the cardiac resynchronization therapy defibrillator (crt-d) recorded oversensing noise in the right ventricular (rv) channel.Noise oversensing was noted when the patient would sit down on his bed, possibly due to an electrical nearby.All other measurements were stable, and noise was not able to be reproduced.Boston scientific technical services provided troubleshooting steps to rule out mechanical and lead impairment.There were no adverse patient effects reported.This device and rv lead remain in-service.Additional information was provided, it was reported that new latitide data transmission was sent for review.Boston scientific technical services observed noise oversensing on the rv channel with pacing inhibition longer than two seconds.The rv lead pacing and shock impedance trends showed a little decrease.There was no out of range impedance measurement so far.Troubleshooting steps were provided to exclude lead impairment.No adverse patient effects were reported.The device and rv lead remain in-service.

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 cardiac resynchronization therapy defibrillator (crt-d) recorded oversensing noise in the right ventricular (rv) channel.Noise oversensing was noted when the patient would sit down on his bed, possibly due to an electrical nearby.All other measurements were stable, and noise was not able to be reproduced.Boston scientific technical services provided troubleshooting steps to rule out mechanical and lead impairment.There were no adverse patient effects reported.This device and rv lead remain in-service.Additional information was provided, it was reported that new latitide data transmission was sent for review.Boston scientific technical services observed noise oversensing on the rv channel with pacing inhibition longer than two seconds.The rv lead pacing and shock impedance trends showed a little decrease.There was no out of range impedance measurement so far.Troubleshooting steps were provided to exclude lead impairment.No adverse patient effects were reported.The device and rv lead remain in-service.

• Brand Name: VIGILANT 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: 18658467
• MDR Text Key: 334742724
• Report Number: 2124215-2024-06848
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2024

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: 05/26/2023
• Device Model Number: G224
• Device Catalogue Number: G224
• Device Lot Number: 503905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 02/07/2024; 02/21/2024
• Supplement Dates FDA Received: 02/12/2024; 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1