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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; IMPLANTABLE DEFIBRILLATOR
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BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; IMPLANTABLE DEFIBRILLATOR Back to Search Results
Model Number G247
Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Over-Sensing (1438); Pacing Problem (1439); Pocket Stimulation (1463); High Capture Threshold (3266)
Patient Problem Device Overstimulation of Tissue (1991)
Event Date 11/01/2022
Event Type  Injury  
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited noise, oversensing and pacing inhibition on the right ventricular channel and high capture thresholds on the right atrial and left ventricular channels.Additionally, the right atrial lead was exhibiting muscle stimulation, oversensing and loss of capture.X-rays were performed which were inconclusive.Reprograming of the device and a potential lead revision were discussed.This device was explanted and another one was implanted instead.This device is expected to be returned for analysis.No further adverse patient effects were reported.
 
Manufacturer Narrative
Additional information corrected on the following fields: h6: impact codes.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited noise, oversensing and pacing inhibition on the right ventricular channel and high capture thresholds on the right atrial and left ventricular channels.Additionally, the right atrial lead was exhibiting muscle stimulation, oversensing and loss of capture.X-rays were performed which were inconclusive.Reprograming of the device and a potential lead revision were discussed.This device was explanted and another one was implanted instead.This device is expected to be returned for analysis.No further adverse patient effects were reported.
 
Manufacturer Narrative
The returned device was 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.Pacing and sensing functions were tested and the device was verified to operate as expected.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) exhibited noise, oversensing and pacing inhibition on the right ventricular channel and high capture thresholds on the right atrial and left ventricular channels.Additionally, the right atrial lead was exhibiting muscle stimulation, oversensing and loss of capture.X-rays were performed which were inconclusive.Reprograming of the device and a potential lead revision were discussed.This device was explanted and another one was implanted instead.This device is expected to be returned for analysis.No further adverse patient effects were reported.
 
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Brand Name
VIGILANT X4 CRT-D
Type of Device
IMPLANTABLE 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 Key15847250
MDR Text Key304170798
Report Number2124215-2022-48555
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 12/23/2022
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 Model NumberG247
Device Catalogue NumberG247
Device Lot Number289495
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/23/2022
Initial Date FDA Received11/22/2022
Supplement Dates Manufacturer Received11/23/2022
12/05/2022
Supplement Dates FDA Received11/23/2022
12/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/29/2022
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) Required Intervention; Hospitalization;
Patient Age77 YR
Patient SexFemale
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