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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 Defective Device (2588)
Patient Problem Device Overstimulation of Tissue (1991)
Event Date 01/18/2022
Event Type  Injury  
Manufacturer Narrative
The product has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.
 
Event Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced phrenic stimulation.The device was surgically explanted.No additional adverse patient effects were reported.
 
Manufacturer Narrative
The product has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.
 
Event Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced phrenic stimulation.The device was surgically explanted.No additional adverse patient effects were reported.Additional information was received that this patient actually passed away prior to the original allegation of phrenic nerve stimulation.Attempts to gather additional information were unsuccessful.There are no allegations or indications of a device malfunction related to the patients death.The device has been returned to boston scientific.
 
Manufacturer Narrative
The product has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.The device was 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 abnormal device characteristics that would have caused or contributed to the reported clinical observations.Muscle stimulation is a known medical risk for implanted pulse generator systems.
 
Event Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced phrenic stimulation.The device was surgically explanted.No additional adverse patient effects were reported.Additional information was received that this patient actually passed away prior to the original allegation of phrenic nerve stimulation.Attempts to gather additional information were unsuccessful.There are no allegations or indications of a device malfunction related to the patients death.The device has been returned to boston scientific.
 
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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 Key16994186
MDR Text Key315862139
Report Number2124215-2023-25997
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526589287
UDI-Public00802526589287
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010012/S436
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,Followup
Report Date 07/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/06/2023
Device Model NumberG247
Device Catalogue NumberG247
Device Lot Number252301
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/28/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/14/2021
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 Age66 YR
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