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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number G146
Device Problem Telemetry Discrepancy (1629)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2022
Event Type  malfunction  
Manufacturer Narrative
This device expected to be returned.Should additional information become available this investigation will be updated.
 
Event Description
It was reported that when performing pre-implant testing it was not possible to interrogate this device.The device was thus not used and was expected to be returned.No adverse patient effects were reported.
 
Event Description
It was reported that when performing pre-implant testing it was not possible to interrogate this device.The device was thus not used and was expected to be returned.No adverse patient effects were reported.
 
Manufacturer Narrative
This report is being filed to update the patient identifier.
 
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.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 when performing pre-implant testing it was not possible to interrogate this device.The device was thus not used and was expected to be returned.No adverse patient effects were reported.
 
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Brand Name
INOGEN 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 Key16032939
MDR Text Key307704244
Report Number2124215-2022-54318
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P010012/S341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 07/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberG146
Device Catalogue NumberG146
Device Lot Number391543
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/20/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/05/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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