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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
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BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR Back to Search Results
Model Number G247
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Unspecified Infection (1930)
Event Date 04/15/2022
Event Type  Injury  
Event Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) system experienced infection and erosion.Subsequently, the patient underwent a revision procedure and this system was explanted.No additional adverse patient effects were reported.
 
Manufacturer Narrative
This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.Visual inspection found no anomalies.Electrical testing was performed and no anomalies were found.Infection is a known medical risk when the skin barrier is breached.Analysis of the returned product is not able to provide relevant information for infection-related allegations.
 
Event Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) system experienced infection and erosion.Subsequently, the patient underwent a revision procedure and this system was explanted.No additional adverse patient effects were reported.This device has been received for analysis.
 
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Brand Name
VIGILANT X4 CRT-D
Type of Device
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
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 Key14522805
MDR Text Key292811987
Report Number2124215-2022-16287
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526589287
UDI-Public00802526589287
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010012/S436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date10/28/2023
Device Model NumberG247
Device Catalogue NumberG247
Device Lot Number270693
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/04/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/04/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age80 YR
Patient SexMale
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