MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G247

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Discomfort (2330); Pericardial Effusion (3271)

Event Date 07/14/2022

Event Type  Injury  

Event Description

It was reported that patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced discomfort in the back and underwent a procedure due to pericardial effusion.All lead measurements were normal and there was no evidence of perforation.The patient's symptoms went away with nsaids.Multiple tests were performed to diagnose pericardial effusion and it was drained.The device left intact and remains in service as it was entirely normal.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced discomfort in the back and underwent a procedure due to pericardial effusion.All lead measurements were normal and there was no evidence of perforation.The patient's symptoms went away with nsaids.Multiple tests were performed to diagnose pericardial effusion and it was drained.The device left intact and remains in service as it was entirely normal.No additional adverse patient effects were reported.Additional information from the field indicated that the exact cause of the effusion was unknown.The physician was suspecting this may have been related to the procedure since the symptoms occurred after the patient was discharged.The device left intact and remains in service as it was entirely normal.No additional adverse patient effects were reported.

• Brand Name: VIGILANT X4 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: 15196922
• MDR Text Key: 297569124
• Report Number: 2124215-2022-29892
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589287
• UDI-Public: 00802526589287
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/16/2022

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/13/2024
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 281335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/10/2022
• Supplement Dates Manufacturer Received: 08/10/2022
• Supplement Dates FDA Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2022
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Female