Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number G247
Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/26/2024
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was an attempted implant during a scheduled therapy upgrade procedure.During implant testing, there was oversensing of noise on the right ventricular (rv) lead channel with this crt-d and a new rv lead.This resulted in up to three seconds of pacing inhibition.Troubleshooting was performed including fluoroscopy, pocket manipulations, and trying with new can and new lead respectively.Subsequently, the new crt-d and new rv lead were implanted with clean measurements.This crt-d was removed and returned to boston scientific for further analysis.No additional adverse patient effects were reported outside of the prolonged procedure.
 
Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was an attempted implant during a scheduled therapy upgrade procedure.During implant testing, there was oversensing of noise on the right ventricular (rv) lead channel with this crt-d and a new rv lead.This resulted in up to three seconds of pacing inhibition.Troubleshooting was performed including fluoroscopy, pocket manipulations, and trying with new can and new lead respectively.Subsequently, the new crt-d and new rv lead were implanted with clean measurements.This crt-d was removed and returned to boston scientific for further analysis.No additional adverse patient effects were reported outside of the prolonged procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key18873977
MDR Text Key337312509
Report Number2124215-2024-14498
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526589287
UDI-Public00802526589287
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/12/2024
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 Health Professional
Device Model NumberG247
Device Catalogue NumberG247
Device Lot Number314459
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/26/2024
Initial Date FDA Received03/11/2024
Supplement Dates Manufacturer Received04/11/2024
Supplement Dates FDA Received04/12/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/03/2023
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 Age68 YR
Patient SexMale
-
-