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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) Back to Search Results
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.
 
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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 Key19217597
MDR Text Key341457489
Report Number2124215-2024-26283
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526534591
UDI-Public00802526534591
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010012/S341
Number of Events Reported1
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 Date05/03/2019
Device Model NumberG148
Device Catalogue NumberG148
Device Lot Number170157
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/22/2024
Initial Date FDA Received04/30/2024
Supplement Dates Manufacturer Received04/30/2024
05/02/2024
Supplement Dates FDA Received05/03/2024
05/10/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/17/2017
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age87 YR
Patient SexMale
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