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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 Convert Rhythm (1540); Inaccurate Synchronization (1609)
Patient Problems Cardiac Arrest (1762); Ventricular Fibrillation (2130)
Event Date 12/11/2021
Event Type  Injury  
Event Description
It was reported that this patient with this cardiac resynchronization therapy defibrillator (crt-d) had a pacing feature turned on in which delivered pacing and induced an arrhythmia.The patient received anti-tachycardia pacing (atp) in which was unsuccessful in converting the arrhythmia and instead accelerated the rhythm into ventricular fibrillation (vf).The physician reported having to perform cpr in which the device appropriately detected and delivered a shock in which the rhythm converted.Post a device interrogation was performed and lead measurements were within normal range.At this time, the device remains in service.No additional adverse patient effects were reported.
 
Event Description
It was reported that this patient with this cardiac resynchronization therapy defibrillator (crt-d) had a pacing feature turned on in which delivered pacing and induced an arrhythmia.The patient received anti-tachycardia pacing (atp) in which was unsuccessful in converting the arrhythmia and instead accelerated the rhythm into ventricular fibrillation (vf).The physician reported having to perform cpr in which the device appropriately detected and delivered a shock in which the rhythm converted.Post a device interrogation was performed and lead measurements were within normal range.At this time, the device remains in service.No additional 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 Key13462608
MDR Text Key285337060
Report Number2124215-2022-03371
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 Non-Healthcare Professional
Type of Report Initial
Report Date 02/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/13/2020
Device Model NumberG148
Device Catalogue NumberG148
Device Lot Number197710
Was Device Available for Evaluation? No
Date Manufacturer Received12/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/23/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Life Threatening;
Patient Age64 YR
Patient SexMale
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