MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN CRT-D; IMPLANTABLE DEVICE

Model Number G141

Device Problems Device Alarm System (1012); Signal Artifact/Noise (1036); Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); High Capture Threshold (3266)

Patient Problem Electric Shock (2554)

Event Date 07/19/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited beeping sound.The field representative turned off one half of the duo device in the hospital.This device remains in service.No adverse patient effects were reported.Additional information was received indicating the crt-d system was explanted.The two right ventricular (rv) leads had exhibited out-of-range pace impedance measurements due to rv lead fracture caused by subclavian crush, resulting in high pacing thresholds, noise, oversensing, and inappropriate shocks delivered by the crt-d.One rv lead also exhibited loss of capture.Tachy therapy was then programed off and the patient was equipped with a lifevest until crt-d extraction could occur.The crt-d was explanted and replaced with a non-boston scientific device.A reportedly four-to-five centimeter un-retrieved fragment of the rv lead apex lead was observed during the explant procedure.There was noted patient discomfort and blood loss, and additional surgical intervention was required.The surgery was completed and a new implantable cardioverter defibrillator (icd) system was implanted.No additional adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited beeping sound.The field representative turned off one half of the duo device in the hospital.This device remains in service.No adverse patient effects were reported.Additional information was received indicating the crt-d system was explanted.The two right ventricular (rv) leads had exhibited out-of-range pace impedance measurements due to rv lead fracture caused by subclavian crush, resulting in high pacing thresholds, noise, oversensing, and inappropriate shocks delivered by the crt-d.One rv lead also exhibited loss of capture.Tachy therapy was then programed off and the patient was equipped with a lifevest until crt-d extraction could occur.The crt-d was explanted and replaced with a non-boston scientific device.A reportedly four-to-five centimeter un-retrieved fragment of the rv lead apex lead was observed during the explant procedure.There was noted patient discomfort and blood loss, and additional surgical intervention was required.The surgery was completed and a new implantable cardioverter defibrillator (icd) system was implanted.No additional adverse patient effects were reported.

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.

• Brand Name: INOGEN 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 Key: 17553716
• MDR Text Key: 321219348
• Report Number: 2124215-2023-43734
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534553
• UDI-Public: 00802526534553
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2018
• Device Model Number: G141
• Device Catalogue Number: G141
• Device Lot Number: 115876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female