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

Model Number G247

Device Problems Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Migration (4003)

Patient Problem Electric Shock (2554)

Event Date 12/13/2021

Event Type  Injury  

Event Description

It was reported that the right ventricular (rv) lead exhibited oversensing of intrinsic atrial beats resulting in multiple episodes with inappropriate anti-tachycardia pacing (atp) device therapy and inappropriate device shocks.Therapy was not exhausted.It was subsequently discovered that this cardiac resynchronization therapy defibrillator (crt-d) device had flipped multiple times within the pocket which pulled the leads and caused all the leads to dislodge from the heart.As a result, the rv lead, the right atrial (ra) lead and the left ventricular (lv) lead were all explanted and replaced, and this crt-d device was repositioned and remains in-service.No additional 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
• 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: 13262256
• MDR Text Key: 284005453
• Report Number: 2124215-2022-00779
• 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: Physician
• Type of Report: Initial
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/19/2022
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 234699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 47 YR
• Patient Sex: Female