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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
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BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR Back to Search Results
Model Number G148
Device Problems Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); High Capture Threshold (3266)
Patient Problems Electric Shock (2554); Shock from Patient Lead(s) (3162)
Event Date 09/10/2023
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that this system with a cardiac resynchronization therapy defibrillator (crt-d) and a right ventricular (rv) lead showed possible t wave over sensing or cross talk.Also, the patient got inappropriate shock during sinus tachycardia.Pacing threshold for the rv lead was high but impedances were steady on the low side.Sounds like patient was intimate with their partner at the time but didn't want to talk about it.Programming options were discussed for this system.The crt-d and the rv remain in service.No additional adverse patient effects were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that this system with a cardiac resynchronization therapy defibrillator (crt-d) and a right ventricular (rv) lead showed possible t wave over sensing or cross talk.Also, the patient got inappropriate shock during sinus tachycardia.Pacing threshold for the rv lead was high but impedances were steady on the low side.Sounds like patient was intimate with their partner at the time but didn't want to talk about it.Programming options were discussed for this system.Additional information was received from the field mentioning that the patient received more inappropriate shocks for cross talk from the right atrial channel on the rv channel.This was the same reason the patient got an electric shock last time.The crt-d had been reprogrammed around sensitivity but more reprograming options were discussed.An x ray analysis was recommended for this patient to determine if there was a change in lead position on integrity.More information was received from the field mentioning that new medication was going to be recommended to suppress the atrial arrhythmias causing the far field noise.Also sensitivity was recommended to be increased and a defibrillation threshold (dft) test was recommended but there is no evidence supporting the completion of the dft process.The crt-d and the rv lead remain in service.No additional adverse patient effects were reported.
 
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Brand Name
INOGEN X4 CRT-D
Type of Device
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
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 Key17849654
MDR Text Key324660943
Report Number2124215-2023-53878
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526534591
UDI-Public00802526534591
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010012/S341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/24/2016
Device Model NumberG148
Device Catalogue NumberG148
Device Lot Number102931
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/17/2014
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; Other;
Patient Age75 YR
Patient SexMale
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