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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN EL ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION INOGEN EL ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number D140
Device Problems Failure to Capture (1081); Pacing Problem (1439); Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978)
Patient Problem Syncope/Fainting (4411)
Event Date 02/21/2023
Event Type  Injury  
Manufacturer Narrative
At this time the device has not been returned.Therefore a technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.If the device is returned, product analysis will be completed, and an updated supplemental report will be submitted.
 
Event Description
It was reported during a routine device change out, after the wound closer, there was 6 seconds of pacing inhibition, loss of capture and the patient experienced syncope episode.The patient was brought back into the cath lab.The physician believed there to be a foreign material in the header of the device that was implanted.The device was surgically removed.A new device was implanted successfully.No adverse patient effects were reported.This device is expected to be returned for analysis.
 
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.Dimensional analysis of the header was completed.Each port measured as expected.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 during a routine device change out, after the wound closer, there was 6 seconds of pacing inhibition, loss of capture and the patient experienced syncope episode.The patient was brought back into the cath lab.The physician believed there to be a foreign material in the header of the device that was implanted.The device was surgically removed.A new device was implanted successfully.No adverse patient effects were reported.This device was returned and analysis completed.
 
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Brand Name
INOGEN EL ICD VR
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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 Key16455708
MDR Text Key310379390
Report Number2124215-2023-09431
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P960040/S306
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberD140
Device Catalogue NumberD140
Device Lot Number309765
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
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