MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; IMPLANTABLE DEVICE

Model Number G247

Device Problem High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2020

Event Type  malfunction  

Event Description

It was reported that the shock lead impedance measured just out-of-range at 126 ohms.When checked several days later the impedance was between 90 and 94 ohms.Technical services discussed programming adjustments.At this time, both the cardiac resynchronization therapy defibrillator and right ventricular lead remain in service and no adverse patient effects were reported.

Event Description

It was reported that the shock lead impedance measured just out-of-range at 126 ohms.When checked several days later the impedance was between 90 and 94 ohms.Technical services discussed programming adjustments.At this time, both the cardiac resynchronization therapy defibrillator and right ventricular lead remain in service and no adverse patient effects were reported.It was additionally reported that there was another alert for impedance of 125 ohms.An x-ray was performed and was normal and ts discussed the possibility of the impedance variance being patient-related.Further programming adjustments were discussed and no adverse patient effects were reported.

• Brand Name: VIGILANT X4 CRT-D
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11105294
• MDR Text Key: 224884824
• Report Number: 2124215-2020-27221
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589287
• UDI-Public: 00802526589287
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

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: 07/29/2021
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 221622
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 01/03/2021
• Supplement Dates Manufacturer Received: 12/23/2020
• Supplement Dates FDA Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR