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); Use of Device Problem (1670); Low impedance (2285)

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

Event Date 03/13/2024

Event Type  malfunction  

Event Description

It was reported that the sleep incline sensor of this cardiac resynchronization therapy defibrillator (crt-d) was not providing values.Review of device data by boston scientific technical services determined that the crt-d also exhibiting oversensing of noise and multiple low out of range pacing impedance measurements of less than 200 ohms on the right ventricular channel.The crt-d remains in service and no adverse patient effects were reported.

• 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: 19013232
• MDR Text Key: 339036035
• Report Number: 2124215-2024-19438
• 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
• Report Date: 04/01/2024

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 Model Number: G224
• Device Catalogue Number: G224
• Device Lot Number: 515016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1