MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

Model Number G141

Device Problems High impedance (1291); Over-Sensing (1438); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2022

Event Type  malfunction  

Event Description

It was reported that there was high impedances out of range observed on the right atrial (ra) channel of this cardiac resynchronization therapy defibrillator (crt-d) system.Technical services (ts) reviewed device strips, and determined there were atrial tachy response (atr) related to minute ventilation (mv) and respiratory rate trend (rrt) oversensing.A spring contact issue was suspected.Ts discussed troubleshooting and programming options.No adverse patient effects were reported.This product remains in-service.

Event Description

It was reported that there was high impedances out of range observed on the right atrial (ra) channel of this cardiac resynchronization therapy defibrillator (crt-d) system.Technical services (ts) reviewed device strips, and determined there were atrial tachy response (atr) related to minute ventilation (mv) and respiratory rate trend (rrt) oversensing.A spring contact issue was suspected.Ts discussed troubleshooting and programming options.No adverse patient effects were reported.This product remains in-service.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv) sensor that is related to intermittent increases in impedance measurements.Additionally, engineering analysis and testing of returned products has identified that any repeated, small movements of the lead terminal ring can create wearing of the lead terminal ring and generate microscopic particles, which may accumulate and oxidize over time.This can impact the connection between the spring contact and the lead ring, resulting in intermittent changes in impedance measurements.Please refer to the description field for more information regarding the specific circumstances of this event.

• Brand Name: INOGEN CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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: 16913937
• MDR Text Key: 315086044
• Report Number: 2124215-2023-23442
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/11/2021
• Device Model Number: G141
• Device Catalogue Number: G141
• Device Lot Number: 137238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2019
• 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 Age: 59 YR
• Patient Sex: Male