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); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885)

Patient Problems Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) device was suspected to have delivered inappropriate anti-tachycardia pacing (atp) therapy due to oversensed noise signals in the right ventricular (rv) channel.The health care professional (hcp) requested technical services (ts) to review this device stored data.Ts reviewed the presenting electrogram (egm) and noted inhibition of biventricular pacing for over two seconds, but patient retained their intrinsic rhythm.Ts was able to confirm the atp therapy was inappropriate.It was also noted the rv amplitude and impedance measurements to be stable and recommended for an in clinic visit for further evaluation of lead integrity.The lead remains in service.No adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) device was suspected to have delivered inappropriate anti-tachycardia pacing (atp) therapy due to oversensed noise signals in the right ventricular (rv) channel.The health care professional (hcp) requested technical services (ts) to review this device stored data.Ts reviewed the presenting electrogram (egm) and noted inhibition of biventricular pacing for over two seconds, but patient retained their intrinsic rhythm.Ts was able to confirm the atp therapy was inappropriate.It was also noted the rv amplitude and impedance measurements to be stable and recommended for an in clinic visit for further evaluation of lead integrity.The lead remains in service.No adverse patient effects were reported.Subsequent additional information was received that reported during an emergency room (er) visit, this cardiac resynchronization therapy defibrillator (crt-d), the health care professional (hcp) requested technical services (ts) consultation to evaluate stored shock episodes.Ts reviewed the electrogram (egm) and noted inappropriate shock therapy was delivered possibly due to noise in the rv lead.It was also reported that the rv lead shock and pacing impedance measurements were recorded to be high out of range and the crtd battery had been depleted and recorded to have reached elective replacement indicator (eri) status.Ts recommended the hcp to consult the cardiologist for further device evaluation.The products remain in service.No additional adverse patient effects were reported.Subsequent additional information received reported that the physician suspected a fracture on this rv lead.The physician performed a revision procedure explanting the crtd device and rv lead.The crtd and rv lead were successfully replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a product performance issue or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) device was suspected to have delivered inappropriate anti-tachycardia pacing (atp) therapy due to oversensed noise signals in the right ventricular (rv) channel.The health care professional (hcp) requested technical services (ts) to review this device stored data.Ts reviewed the presenting electrogram (egm) and noted inhibition of biventricular pacing for over two seconds, but patient retained their intrinsic rhythm.Ts was able to confirm the atp therapy was inappropriate.It was also noted the rv amplitude and impedance measurements to be stable and recommended for an in clinic visit for further evaluation of lead integrity.The lead remains in service.No adverse patient effects were reported.Subsequent additional information was received that reported during an emergency room (er) visit, this cardiac resynchronization therapy defibrillator (crt-d), the health care professional (hcp) requested technical services (ts) consultation to evaluate stored shock episodes.Ts reviewed the electrogram (egm) and noted inappropriate shock therapy was delivered possibly due to noise in the rv lead.It was also reported that the rv lead shock and pacing impedance measurements were recorded to be high out of range and the crtd battery had been depleted and recorded to have reached elective replacement indicator (eri) status.Ts recommended the hcp to consult the cardiologist for further device evaluation.The products remain in service.No additional adverse patient effects were reported.Subsequent additional information received reported that the physician suspected a fracture on this rv lead.The physician performed a revision procedure explanting the crtd device and rv lead.The crtd and rv lead were successfully replaced.No additional adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) device was suspected to have delivered inappropriate anti-tachycardia pacing (atp) therapy due to oversensed noise signals in the right ventricular (rv) channel.The health care professional (hcp) requested technical services (ts) to review this device stored data.Ts reviewed the presenting electrogram (egm) and noted inhibition of biventricular pacing for over two seconds, but patient retained their intrinsic rhythm.Ts was able to confirm the atp therapy was inappropriate.It was also noted the rv amplitude and impedance measurements to be stable and recommended for an in clinic visit for further evaluation of lead integrity.The lead remains in service.No adverse patient effects were reported.Subsequent additional information was received that reported during an emergency room (er) visit, this cardiac resynchronization therapy defibrillator (crt-d), the health care professional (hcp) requested technical services (ts) consultation to evaluate stored shock episodes.Ts reviewed the electrogram (egm) and noted inappropriate shock therapy was delivered possibly due to noise in the rv lead.It was also reported that the rv lead shock impedance measurements were recorded to be high out of range and the crtd battery had been depleted and recorded to have reached elective replacement indicator (eri) status.Ts recommended the hcp to consult the cardiologist for further device evaluation.The products remain in service.No additional adverse patient effects were reported.

• 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: 18178957
• MDR Text Key: 328633110
• Report Number: 2124215-2023-65555
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/27/2017
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 129303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2015
• 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 Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male