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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
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BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number G247
Device Problem Over-Sensing (1438)
Patient Problems Fatigue (1849); Dizziness (2194); Diaphoresis (2452)
Event Date 03/03/2023
Event Type  malfunction  
Event Description
It was reported that this patient felt light-headed, a lack of energy, and cold sweats the past few days.Technical services (ts) analyzed the presenting electrogram (egm) of this cardiac resynchronization therapy defibrillator (crt-d) and determined that this patient was possibly experiencing chronic atrial fibrillation (af) as well as premature ventricular contractions (pvc) on the right ventricular (rv) channel.Ts discussed device programming with health care professional (hcp).It was discovered that there was a stored signal artifact monitoring (sam) episode due to oversensing of electromagnetic interference (emi) during an ablation procedure which disabled the respiratory rate trend (rrt) feature of this device.There was no evidence of pacing inhibition observed.Ts recommended that this feature be turned back on during next clinic visit.No additional adverse patient effects were reported.Currently, this crt-d remains in service.
 
Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing of noise generated by the respiratory sensor that is related to a high impedance condition.Please see the description for more information regarding the specific circumstances of this event.
 
Event Description
It was reported that this patient felt light-headed, a lack of energy, and cold sweats the past few days.Technical services (ts) analyzed the presenting electrogram (egm) of this cardiac resynchronization therapy defibrillator (crt-d) and determined that this patient was possibly experiencing chronic atrial fibrillation (af) as well as premature ventricular contractions (pvc) on the right ventricular (rv) channel.Ts discussed device programming with health care professional (hcp).It was discovered that there was a stored signal artifact monitoring (sam) episode due to oversensing of electromagnetic interference (emi) during an ablation procedure which disabled the respiratory rate trend (rrt) feature of this device.There was no evidence of pacing inhibition observed.Ts recommended that this feature be turned back on during next clinic visit.No additional adverse patient effects were reported.Currently, this crt-d remains in service.
 
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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 Key16644158
MDR Text Key312330567
Report Number2124215-2023-14944
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberG247
Device Catalogue NumberG247
Device Lot Number291957
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/28/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/06/2022
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 Age64 YR
Patient SexMale
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