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

Model Number G141

Device Problem Pacing Problem (1439)

Patient Problems Bradycardia (1751); Cardiac Enzyme Elevation (1838); Fall (1848); Syncope/Fainting (4411)

Event Date 08/21/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this patient with an implanted cardiac resynchronization therapy defibrillator (crt-d) system passed out and collapsed at church.It was indicated that their heart rate was down to 45 beats per minute.The patient was transported to the hospital.It was noted that the patients enzyme levels were high.The patients wife contacted boston scientific technical services (ts) to inquire if a boston scientific field representative would be coming to the hospital.Ts discussed representative availability and provided guidance to continue to work with the healthcare providers to determine the care plan for the patient.Subsequent information provided by a boston scientific field representative indicated they were not sure what caused the syncope, what actions were taken or what the resolution was for the patient.The crt-d device remains in-service.It was noted that no additional adverse patient effects were reported.

Event Description

It was reported that this patient with an implanted cardiac resynchronization therapy defibrillator (crt-d) system passed out and collapsed at church.It was indicated that their heart rate was down to 45 beats per minute.The patient was transported to the hospital.It was noted that the patient's enzyme levels were high.The patients wife contacted boston scientific technical services (ts) to inquire if a boston scientific field representative would be coming to the hospital.Ts discussed representative availability and provided guidance to continue to work with the healthcare providers to determine the care plan for the patient.Subsequent information provided by a boston scientific field representative indicated they were not sure what caused the syncope, what actions were taken or what the resolution was for the patient.The crt-d device remains in-service.It was noted that no additional adverse patient effects were reported.Additional information was received that this crt-d device was subsequently explanted and replaced due to normal battery depletion more than a year after the reported event.The device was returned to boston scientific for analysis.No adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.The device was 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: 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: 15370717
• MDR Text Key: 299380740
• Report Number: 2124215-2022-34663
• Device Sequence Number: 1
• Product Code: NIK
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

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 Date: 02/26/2017
• Device Model Number: G141
• Device Catalogue Number: G141
• Device Lot Number: 108579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 08/22/2022
• Initial Date FDA Received: 09/07/2022
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male