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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 G148
Device Problems Pacing Problem (1439); Inaccurate Synchronization (1609)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/12/2022
Event Type  Injury  
Manufacturer Narrative
No additional information is available.If additional information becomes available the report will be updated at that time.
 
Event Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) delivered anti-tachycardia pacing (atp) for ventricular tachycardia (vt).The physician was concerned that the biventricular trigger may have contributed as two third beats of triggered pacing occurred prior to vt.Ts was consulted to review the episode.
 
Event Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) delivered anti-tachycardia pacing (atp) for ventricular tachycardia (vt).The physician was concerned that the biventricular (biv) trigger may have contributed as two third beats of triggered pacing occurred prior to vt.Ts was consulted to review the episode.Upon review of the data, ts noted that generally pacing did occur prior to the elevated rates periods.However ts discussed that it would be up to physician determination if the pacing events were the triggers for the high rates as one of a cr-t device's functions is to try to pace the ventricles as much percent as possible.Ts further observed left ventricular (lv) pacing inhibition while the biv trigger was functioning in some episodes, while in others there was lv pacing with the biv trigger.
 
Manufacturer Narrative
No additional information is available.If additional information becomes available the report will be updated at that time.
 
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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 Key16109624
MDR Text Key306777850
Report Number2124215-2022-56044
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526534591
UDI-Public00802526534591
Combination Product (y/n)N
Reporter Country CodeEI
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date05/14/2017
Device Model NumberG148
Device Catalogue NumberG148
Device Lot Number134161
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/14/2015
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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