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); Inaccurate Synchronization (1609)

Patient Problems Ventricular Fibrillation (2130); Asystole (4442)

Event Date 01/04/2024

Event Type  Injury  

Event Description

It was reported that at the end of a successful threshold test during a routine follow up, there was a pause with no brady pacing that resulted in a ventricular fibrillation (vf) episode.The device delivered shock therapy, which successfully terminated the rhythm.The patient was then hospitalized as they have a history of vf and during that time, the device recorded two vf episodes that included some oversensing of artifacts noise on the right ventricular (rv) channel and noise on the shock channel.Movement and manipulation techniques did not result in noise, all shock deliveries showed normal impedance values and no other episodes were recorded.The physician requested review of the episodes as they believed this noise could possibly be related to external equipment.Boston scientific technical services (ts) reviewed data from the device and excluded an implantable device deficiency, as all data appears to be normal, and no resets, faults or unusual behavior were identified.Ts explained that the artifacts seen in the episodes do not match the pattern of electromagnetic interference (emi), so lead impairment is suspected to be the cause of the observations.Rv lead replacement was recommended and later on, this implantable device and the lead were explanted and replaced.No additional adverse patient effects were reported.Product return availability information was requested to the field.

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed, and this report will be updated at that time.

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed, and this report will be updated at that time.

Event Description

It was reported that at the end of a manual right ventricular (rv) threshold test during a routine follow up, there was a pause with no brady pacing that resulted in a ventricular fibrillation (vf) episode.The manual rv threshold test showed loss of capture when the output decreased to 0.9 volts; however, four additional paces occurred at sub-threshold outputs before the manual test was ended.The additional paces at sub-threshold outputs did not capture, resulting in ventricular asystole for approximately 3 seconds before the threshold test ended and pacing at normal outputs resumed with capture.Following the first captured rv pace, after the 3 second period of asystole, the patient experienced vf which was appropriately detected and converted by the device with delivery of shock therapy.The patient was hospitalized as they have a history of vf and during that time, the device recorded two vf episodes that included some oversensing of artifacts noise on the right ventricular (rv) channel and noise on the shock channel, with associated pacing inhibition.Movement and manipulation techniques did not result in noise, all shock deliveries showed normal impedance values and no other episodes were recorded.The physician requested review of the episodes as they believed this noise could possibly be related to external equipment.Boston scientific technical services (ts) reviewed data from the device and excluded an implantable device deficiency, as all data appears to be normal, and no resets, faults or unusual behavior were identified.Ts explained that the artifacts seen in the episodes do not match the pattern of electromagnetic interference (emi), so lead impairment is suspected to be the cause of the observations.Rv lead replacement was recommended and later on, this implantable device and the rv lead were explanted and replaced.No additional adverse patient effects were reported.Product return availability information was requested to the field.Additional information was received.It was a clinical decision to preventively replace this device.Additional information was received.Boston scientific has been informed that the patient did not sign the consent form as per mpdg section 72 (6) to allow return of the product for analysis.The physician involved was contacted for further information, and they explained that the patient had difficulties going back to the hospital to sign the consent form.The device is not expected to return to boston scientific for analysis.If patient consent is provided, and the device is returned in the future, analysis will be performed.

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed, and this report will be updated at that time.

Event Description

It was reported that at the end of a successful threshold test during a routine follow up, there was a pause with no brady pacing that resulted in a ventricular fibrillation (vf) episode.The device delivered shock therapy, which successfully terminated the rhythm.The patient was then hospitalized as they have a history of vf and during that time, the device recorded two vf episodes that included some oversensing of artifacts noise on the right ventricular (rv) channel and noise on the shock channel.Movement and manipulation techniques did not result in noise, all shock deliveries showed normal impedance values and no other episodes were recorded.The physician requested review of the episodes as they believed this noise could possibly be related to external equipment.Boston scientific technical services (ts) reviewed data from the device and excluded an implantable device deficiency, as all data appears to be normal, and no resets, faults or unusual behavior were identified.Ts explained that the artifacts seen in the episodes do not match the pattern of electromagnetic interference (emi), so lead impairment is suspected to be the cause of the observations.Rv lead replacement was recommended and later on, this implantable device and the lead were explanted and replaced.No additional adverse patient effects were reported.Product return availability information was requested to the field.Additional information was received.It was a clinical decision to preventively replace this device.

• 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: 18627526
• MDR Text Key: 334367314
• Report Number: 2124215-2024-05715
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/17/2019
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 163592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2017
• 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): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 61 YR