MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

Model Number G148

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Use of Device Problem (1670)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 04/19/2024

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) presented oversensing of noisy signals on its right atrial (ra) and right ventricular (rv) channels.The rv channel oversensing resulted in the delivery of one burst of anti-tachycardia pacing (atp) and two shocks.Technical services (ts) was consulted on the episodes and advised the noisy signals could be due to oversensing of electromagnetic interference (emi).Further review of stored episodes, revealed a false positive recording of pacemaker mediated tachycardia (pmt) for elevated atrial rates.This cardiac resynchronization therapy defibrillator (crt-d) remains in service.No additional adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) presented oversensing of noisy signals on its right atrial (ra) and right ventricular (rv) channels.The rv channel oversensing resulted in the delivery of one burst of anti-tachycardia pacing (atp) and two shocks.Technical services (ts) was consulted on the episodes and advised the noisy signals could be due to oversensing of electromagnetic interference (emi).Further review of stored episodes, revealed a false positive recording of pacemaker mediated tachycardia (pmt) for elevated atrial rates.This cardiac resynchronization therapy defibrillator (crt-d) remains in service.No additional adverse patient effects were reported.Additional information received indicates the patient was using a transcutaneous electrical nerve stimulation (tens) unit and this was the cause for the emi that was oversensed.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) presented oversensing of noisy signals on its right atrial (ra) and right ventricular (rv) channels.The rv channel oversensing resulted in the delivery of one burst of anti-tachycardia pacing (atp) and two shocks.Technical services (ts) was consulted on the episodes and advised the noisy signals could be due to oversensing of electromagnetic interference (emi).Further review of stored episodes, revealed a false positive recording of pacemaker mediated tachycardia (pmt) for elevated atrial rates.This cardiac resynchronization therapy defibrillator (crt-d) remains in service.No additional adverse patient effects were reported.Additional information received indicates the patient was using a transcutaneous electrical nerve stimulation (tens) unit and this was the cause for the emi that was oversensed.Additional information received indicates the patient received the shocks while they were undergoing spine surgery, with the information indicating the lack of magnet application as the root cause of the inappropriate shock delivery since the noisy signals were caused by the medical equipment used during the procedure instead of the previously reported tens unit.

• Brand Name: INOGEN X4 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: 19217597
• MDR Text Key: 341457489
• Report Number: 2124215-2024-26283
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: 00802526534591
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/03/2019
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 170157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 04/30/2024; 05/02/2024
• Supplement Dates FDA Received: 05/03/2024; 05/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 87 YR
• Patient Sex: Male