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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 Problems Connection Problem (2900); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2023
Event Type  Injury  
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was explanted due to damage noted during a lead revision procedure.While implanting a right ventricular (rv) lead and connecting the lead to the crt-d, damage to the insulation on the screw of the header was detected.It was not known if the damage was caused by the user or if it was damaged prior.The crt-d was explanted and replaced with a new device.No additional adverse patient effects were reported.The device will return for analysis.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was explanted due to damage noted during a lead revision procedure.While implanting a right ventricular (rv) lead and connecting the lead to the crt-d, damage to the insulation on the screw of the header was detected.It was not known if the damage was caused by the user or if it was damaged prior.The crt-d was explanted and replaced with a new device.No additional adverse patient effects were reported.The device was return for analysis.
 
Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual inspection found damage to the rv seal plug consistent with reports, further inspection found port is missing set screw.There was also damage noted on outside of header around seal plug, likely caused by removal of device from pocket.Replacement set screw was inserted into the device and the device was then exposed to simulated heart load conditions, 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.Laboratory analysis of the returned device found the device to be missing a set screw, it is however unclear at what point the set screw was lost and cause cannot be established.
 
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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 Key16435873
MDR Text Key310149541
Report Number2124215-2023-08678
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526534539
UDI-Public00802526534539
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P010012/S341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date12/05/2021
Device Model NumberG140
Device Catalogue NumberG140
Device Lot Number497175
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/09/2023
Initial Date FDA Received02/24/2023
Supplement Dates Manufacturer Received08/31/2023
Supplement Dates FDA Received09/01/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/17/2019
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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