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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; IMPLANTABLE DEVICE
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BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; IMPLANTABLE DEVICE Back to Search Results
Model Number G148
Device Problems Failure to Capture (1081); Over-Sensing (1438); Pacing Problem (1439)
Patient Problem Dizziness (2194)
Event Date 10/21/2023
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited oversensing of the atrial channel resulting in loss of capture and pacing inhibition.The patient was reported to have experienced dizziness.Further evaluation is expected to be completed at the next follow up appointment.This device remains in service.No adverse patient effects were reported.
 
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Brand Name
INOGEN X4 CRT-D
Type of Device
IMPLANTABLE DEVICE
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 Key18057945
MDR Text Key327198130
Report Number2124215-2023-61452
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P010012/S341
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
Report Date 11/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/16/2020
Device Model NumberG148
Device Catalogue NumberG148
Device Lot Number196394
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/21/2023
Initial Date FDA Received11/02/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/02/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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