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

Model Number G141

Device Problem Interrogation Problem (4017)

Patient Problems Syncope (1610); Syncope/Fainting (4411)

Event Date 10/25/2020

Event Type  Injury  

Event Description

It was reported that this patient presented to the emergency room (er) with unexplained syncope.In addition, a healthcare provider (hcp) contacted boston scientific technical services (ts) on the same day to solicit troubleshooting assistance due to the inability to interrogate the patients cardiac resynchronization therapy defibrillator device with a communicator.Ts confirmed that the crt-d device is compatible with the type of communicator being used and provided guidance to move the communicator wand around to try to find a location where it communicates with the device.The hcp thought the issue was with the inability to retrieve data from the crt-d device, not an issue with sending data.Ts further discussed communicator and device interaction with the hcp and transferred the hcp to have the local boston scientific representative (rep) paged.Subsequent information from the rep supporting the healthcare facility (hcf) indicates they have no knowledge of this event as they were never paged to see the patient in the er or to follow up on a failed interrogation.Also, the rep reached out to the cardiology office, but the office staff were unaware of the event.In addition, the rep noted that the device was successfully interrogated the day before the patient was reported to have presented to the er and ts reviewed the transmission with physician who reported the patients syncope, according to the communicator transmission report.The cause of the patients syncope is unknown.The device remains in-service.No additional adverse patient effects were reported.

Event Description

It was reported that this patient presented to the emergency room (er) with unexplained syncope.In addition, a healthcare provider (hcp) contacted boston scientific technical services (ts) on the same day to solicit troubleshooting assistance due to the inability to interrogate the patients cardiac resynchronization therapy defibrillator device with a communicator.Ts confirmed that the crt-d device is compatible with the type of communicator being used and provided guidance to move the communicator wand around to try to find a location where it communicates with the device.The hcp thought the issue was with the inability to retrieve data from the crt-d device, not an issue with sending data.Ts further discussed communicator and device interaction with the hcp and transferred the hcp to have the local boston scientific representative (rep) paged.Subsequent information from the rep supporting the healthcare facility (hcf) indicates they have no knowledge of this event as they were never paged to see the patient in the er or to follow up on a failed interrogation.Also, the rep reached out to the cardiology office, but the office staff were unaware of the event.In addition, the rep noted that the device was successfully interrogated the day before the patient was reported to have presented to the er and ts reviewed the transmission with physician who reported the patients syncope, according to the communicator transmission report.The cause of the patients syncope is unknown.The device remains in-service.No additional adverse patient effects were reported.Additional information was received that the crt-d device was subsequently returned to boston scientific approximately 2.5 years later, indicating it was explanted.No other information was provided.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.The device was able to communicate with the programmer.Device diagnostic data confirmed the battery exhibits a pattern consistent with normal battery depletion.Based on analysis of the device memory, the device recorded no faults or resets, the device battery voltage was appropriate, the power usage was normal while implanted, and all therapy was available while the device was implanted.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: 11104148
• MDR Text Key: 224795982
• Report Number: 2124215-2020-26876
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2018
• Device Model Number: G141
• Device Catalogue Number: G141
• Device Lot Number: 118194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 62 YR
• Patient Sex: Male