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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Pain (1994); Tachycardia (2095)
Event Date 04/20/2023
Event Type  Injury  
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system revision due to infection.Also, patient felt pain.There were no additional adverse patient effects reported.The crt-d was explanted.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) had exhibited infection.Also, patient felt pain.A revision was performed and the crt-d along with the right ventricular (rv) lead, right atrial (ra) lead, left ventricular (lv) lead and previously capped rv lead were explanted.No additional adverse patient effects were reported.The crt-d was returned for analysis.This patient also had tachycardia.No additional adverse patient effects were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.Correction to the initial mdr in blocks b5 and h6 patient codes.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.Correction to the initial mdr in blocks b5 and h6 patient codes.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 the patient with this cardiac resynchronization therapy defibrillator (crt-d) had exhibited infection.Also, patient felt pain.A revision was performed and the crt-d along with the right ventricular (rv) lead, right atrial (ra) lead, left ventricular (lv) lead and previously capped rv lead were explanted.No additional adverse patient effects were reported.The crt-d was returned for analysis.This patient also had tachycardia.No additional adverse patient effects were reported.
 
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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 Key16862368
MDR Text Key314483752
Report Number2124215-2023-21500
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,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 05/19/2023
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? No
Device Operator Lay User/Patient
Device Model NumberG247
Device Catalogue NumberG247
Device Lot Number297719
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/25/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/20/2023
Initial Date FDA Received05/03/2023
Supplement Dates Manufacturer Received05/08/2023
05/18/2023
Supplement Dates FDA Received05/09/2023
05/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/09/2023
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) Required Intervention; Hospitalization;
Patient Age66 YR
Patient SexMale
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