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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 Problems Over-Sensing (1438); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/20/2023
Event Type  Injury  
Event Description
It was reported that during the implant procedure of this cardiac resynchronization therapy defibrillator (crt-d) system, the device recorded a signal artifact monitor (sam) episode due to oversensing of noisy signals.As a result, the respiratory rate trend feature was disabled.An air bubble was suspected as well as connection issues since the noise was more prevalent when pressing on the pocket.The physician reopened the pocket to verify connections and reinserted the right ventricular (rv) lead into the header of this device.A few air bubbles were noted after the reintervention, however, the field representative stated this had improved the previous issues observed.No additional adverse patient effects were reported.At this time, this device system remains in service.
 
Event Description
It was reported that during the implant procedure of this cardiac resynchronization therapy defibrillator (crt-d) system, the device recorded a signal artifact monitor (sam) episode due to oversensing of noisy signals.As a result, the respiratory rate trend feature was disabled.An air bubble was suspected as well as connection issues since the noise was more prevalent when pressing on the pocket.The physician reopened the pocket to verify connections and reinserted the right ventricular (rv) lead into the header of this device.A few air bubbles were noted after the reintervention, however, the field representative stated this had improved the previous issues observed.No additional adverse patient effects were reported.At this time, this device system remains in service.
 
Manufacturer Narrative
This product has not been returned for analysis; therefore, no product analysis could be performed.Investigation of the available information determined that the noise on the ventricular channel was consistent with temporary body fluid infiltration through the seal plug, coupled with air escaping the seal plug.Setscrew seal plugs are designed to permit setscrew wrench insertion yet prevent body fluids from entering the header cavities.If an accessory sensing pathway is present due to fluid intrusion, there is a potential for oversensing and, thus, inhibition of pacing or delivery of inappropriate therapy.
 
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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 Key17863749
MDR Text Key324837757
Report Number2124215-2023-54549
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 10/31/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2023
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 Number314419
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/25/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/11/2023
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 Outcome(s) Hospitalization; Required Intervention;
Patient Age79 YR
Patient SexMale
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