MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number	G140
Medical Device Problem Codes	Connection Problem (2900); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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.
Additional 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.

• Brand Name: INOGEN CRT-D
• Common Device Name: 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 Key: 16435873
• Report Number: 2124215-2023-08678
• Device Sequence Number: 17954463
• Product Code: NIK
• UDI-Device Identifier: 00802526534539
• UDI-Public: 00802526534539
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P010012/S341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/05/2021
• Device Model Number: G140
• Device Catalogue Number: G140
• Device Lot Number: 497175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown