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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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BOSTON SCIENTIFIC CORPORATION INOGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number G140
Device Problem High impedance (1291)
Patient Problem Device Overstimulation of Tissue (1991)
Event Date 10/06/2022
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited pacing impedance values of greater than 3000 ohms on all tested vector configurations.Patient experienced stimulation during lv lead vector testing.It was noted that patient had an echocardiogram.Technical services (ts) analyzed presenting electrogram (egm) and found that there was no loss of capture.Subsequently, ts provided troubleshooting including testing impedances measurements on other vectors.Lead replacement was recommended.Patient is scheduled for an echocardiogram.No additional adverse patient effects were reported.Currently, this device remains in service.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited pacing impedance values of greater than 3000 ohms on all tested vector configurations.Patient experienced stimulation during lv lead vector testing.It was noted that patient had an echocardiogram.Technical services (ts) analyzed presenting electrogram (egm) and found that there was no loss of capture.Subsequently, ts provided troubleshooting including testing impedances measurements on other vectors.Lead replacement was recommended.Patient is scheduled for an echocardiogram.No additional adverse patient effects were reported.Currently, this device remains in service.Later, this product was received by boston scientific and full investigation was conducted.
 
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.Dimensional analysis of the header was completed.Each port measured as expected.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.
 
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Brand Name
INOGEN 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 Key15770414
MDR Text Key306811605
Report Number2124215-2022-46487
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526534539
UDI-Public00802526534539
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 04/17/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/10/2017
Device Model NumberG140
Device Catalogue NumberG140
Device Lot Number477554
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/03/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/10/2015
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 Age90 YR
Patient SexMale
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