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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 Migration (4003)
Patient Problem Twiddlers Syndrome (4563)
Event Date 01/30/2023
Event Type  Injury  
Event Description
It was reported that this cardiac resynchronization therapy defibrillator got rotated due to the patient twiddling with it, this was confirmed through x-ray.This device was explanted and successfully replaced.No additional adverse patient effects were reported.
 
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.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 got rotated due to the patient twiddling with it, this was confirmed through x-ray.This device was explanted and successfully replaced.No additional adverse patient effects were reported.
 
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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 Key16353708
MDR Text Key309296174
Report Number2124215-2023-05903
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 Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2023
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 Number287551
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/02/2022
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) Hospitalization; Required Intervention;
Patient Age58 YR
Patient SexFemale
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