MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE LEAD

Model Number 3501

Device Problems Fracture (1260); High impedance (1291); Over-Sensing (1438); Failure to Sense (1559); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581); Under-Sensing (1661)

Patient Problem Electric Shock (2554)

Event Date 07/29/2020

Event Type  Injury  

Event Description

It was reported that the subcutaneous implantable cardioverter defibrillator (s-icd) had stored multiple atrial fibrillation (af) episodes.In one of the episodes there were different morphologies observed.There was no oversensing but there was occasional undersensing noted due to varying amplitude and morphologies.Boston scientific technical services (ts) was consulted and also observed what appeared to be qs, wider signals that occurred in short runs.However, some of these appeared to have a smaller r wave amplitude.Ts discussed programming and medication adjustment considerations.Five months later the patient received two inappropriate shocks due to possible af with varying morphologies.Ts again was consulted and discussed assessing sensing vectors at elevated rates.One month later the patient received an additional two shocks due to supraventricular tachycardia (svt).Ts discussed having the patient perform treadmill testing and capture a reference electrocardiogram at higher rates.A small amount of oversensing was seen in the stored episodes, however it was thought the inappropriate shocks were occurring due to the patient's high heart rate.Approximately one week later the patient has another inappropriate shock for af.The patient's medication was adjusted and the s-icd shock zones were reprogrammed.During the recent interrogation a concern over electrode integrity was discussed as one of the sensing vectors appeared to be flat.Ts suggested an x-ray and additional testing.It was further noted the patient is a recreational drug user which may be contributing to the arrhythmias.The field representative indicated that an x-ray was taken, but the results were unknown.The patient was scheduled to follow up at a different clinic.That field representative noted the patient had to cancel their initial follow up appointment due to weather.The appointment was rescheduled.The s-icd and electrode remain in service and no adverse patient effects were reported.

Event Description

It was reported that the subcutaneous implantable cardioverter defibrillator (s-icd) had stored multiple atrial fibrillation (af) episodes.In one of the episodes there were different morphologies observed.There was no oversensing but there was occasional undersensing noted due to varying amplitude and morphologies.Boston scientific technical services (ts) was consulted and also observed what appeared to be qs, wider signals that occurred in short runs.However, some of these appeared to have a smaller r wave amplitude.Ts discussed programming and medication adjustment considerations.Five months later the patient received two inappropriate shocks due to possible af with varying morphologies.Ts again was consulted and discussed assessing sensing vectors at elevated rates.One month later the patient received an additional two shocks due to supraventricular tachycardia (svt).Ts discussed having the patient perform treadmill testing and capture a reference electrocardiogram at higher rates.A small amount of oversensing was seen in the stored episodes, however it was thought the inappropriate shocks were occurring due to the patient's high heart rate.Approximately one week later the patient has another inappropriate shock for af.The patient's medication was adjusted and the s-icd shock zones were reprogrammed.During the recent interrogation a concern over electrode integrity was discussed as one of the sensing vectors appeared to be flat.Ts suggested an x-ray and additional testing.It was further noted the patient is a recreational drug user which may be contributing to the arrhythmias.The field representative indicated that an x-ray was taken, but the results were unknown.The patient was scheduled to follow up at a different clinic.That field representative noted the patient had to cancel their initial follow up appointment due to weather.The appointment was rescheduled.The s-icd and electrode remain in service and no adverse patient effects were reported.Additional information was received that the remote home monitoring system issued an alert for high out of range shock impedance measurements on the electrode.Boston scientific technical services (ts) was consulted and discussed that the shock impedance was greater than 400 ohms during the weekly test and was an acute change.Review of the primary sensing vector, which was currently programmed, found many atrial fibrillation (af) episodes, some with noise and some without noise.The noise was deemed similar to myopotential, but had a different morphology.Ts noted that the patient should be considered unprotected at this point and suggested scheduling an in-clinic appointment to evaluate with sensing vectors and take x-rays.The patient was brought into the clinic for testing where they were unable to reproduce the noise.The shock impedance was consistently greater than 200 ohms.The alternate sensing vector was noted to be flat, but primary and secondary vectors had appropriate sensing.The patient does not have sternal wires and the electrode header x-ray appeared to confirm full electrode insertion into the header of the subcutaneous implantable cardioverter defibrillator (s-icd).Ts reviewed the x-ray and noted a possible 90 degree bend of the electrode as it comes out of the header of the s-icd.The electrode appeared to have no slack and ts recommended an electrode revision.The clinician called back later and stated that radiology produced an enhanced x-ray which showed the distal portion of the electrode is fractured and separated by one cm along the sternum, not near the header.This was determined to be the likely cause of the stored episodes and high impedance measurements.The field representative will attempt to obtain additional information from the clinic for resolution of the electrode issue.If additional information becomes available the report will be updated at that time.The electrode remains in service at this time.Additional information was received that a revision procedure was performed where the electrode was confirmed to be fractured and separated with visual inspection.The electrode was explanted.The s-icd was also explanted during the revision procedure as the patient was implanted with a transvenous implantable cardioverter defibrillator (icd) system.No additional adverse patient effects were reported.In december 2020, boston scientific issued an advisory notification regarding the potential for emblem s-icd subcutaneous electrodes to exhibit a lead body fracture just distal to the proximal sense ring.This electrode is a part of the advisory population.

Event Description

It was reported that the subcutaneous implantable cardioverter defibrillator (s-icd) had stored multiple atrial fibrillation (af) episodes.In one of the episodes there were different morphologies observed.There was no oversensing but there was occasional undersensing noted due to varying amplitude and morphologies.Boston scientific technical services (ts) was consulted and also observed what appeared to be qs, wider signals that occurred in short runs.However, some of these appeared to have a smaller r wave amplitude.Ts discussed programming and medication adjustment considerations.Five months later the patient received two inappropriate shocks due to possible af with varying morphologies.Ts again was consulted and discussed assessing sensing vectors at elevated rates.One month later the patient received an additional two shocks due to supraventricular tachycardia (svt).Ts discussed having the patient perform treadmill testing and capture a reference electrocardiogram at higher rates.A small amount of oversensing was seen in the stored episodes, however it was thought the inappropriate shocks were occurring due to the patient's high heart rate.Approximately one week later the patient has another inappropriate shock for af.The patient's medication was adjusted and the s-icd shock zones were reprogrammed.During the recent interrogation a concern over electrode integrity was discussed as one of the sensing vectors appeared to be flat.Ts suggested an x-ray and additional testing.It was further noted the patient is a recreational drug user which may be contributing to the arrhythmias.The field representative indicated that an x-ray was taken, but the results were unknown.The patient was scheduled to follow up at a different clinic.That field representative noted the patient had to cancel their initial follow up appointment due to weather.The appointment was rescheduled.The s-icd and electrode remain in service and no adverse patient effects were reported.Additional information was received that the remote home monitoring system issued an alert for high out of range shock impedance measurements on the electrode.Boston scientific technical services (ts) was consulted and discussed that the shock impedance was greater than 400 ohms during the weekly test and was an acute change.Review of the primary sensing vector, which was currently programmed, found many atrial fibrillation (af) episodes, some with noise and some without noise.The noise was deemed similar to myopotential, but had a different morphology.Ts noted that the patient should be considered unprotected at this point and suggested scheduling an in-clinic appointment to evaluate with sensing vectors and take x-rays.The patient was brought into the clinic for testing where they were unable to reproduce the noise.The shock impedance was consistently greater than 200 ohms.The alternate sensing vector was noted to be flat, but primary and secondary vectors had appropriate sensing.The patient does not have sternal wires and the electrode header x-ray appeared to confirm full electrode insertion into the header of the subcutaneous implantable cardioverter defibrillator (s-icd).Ts reviewed the x-ray and noted a possible 90 degree bend of the electrode as it comes out of the header of the s-icd.The electrode appeared to have no slack and ts recommended an electrode revision.The clinician called back later and stated that radiology produced an enhanced x-ray which showed the distal portion of the electrode is fractured and separated by one cm along the sternum, not near the header.This was determined to be the likely cause of the stored episodes and high impedance measurements.The field representative will attempt to obtain additional information from the clinic for resolution of the electrode issue.If additional information becomes available the report will be updated at that time.The electrode remains in service at this time.

Event Description

It was reported that the subcutaneous implantable cardioverter defibrillator (s-icd) had stored multiple atrial fibrillation (af) episodes.In one of the episodes there were different morphologies observed.There was no oversensing but there was occasional undersensing noted due to varying amplitude and morphologies.Boston scientific technical services (ts) was consulted and also observed what appeared to be qs, wider signals that occurred in short runs.However, some of these appeared to have a smaller r wave amplitude.Ts discussed programming and medication adjustment considerations.Five months later the patient received two inappropriate shocks due to possible af with varying morphologies.Ts again was consulted and discussed assessing sensing vectors at elevated rates.One month later the patient received an additional two shocks due to supraventricular tachycardia (svt).Ts discussed having the patient perform treadmill testing and capture a reference electrocardiogram at higher rates.A small amount of oversensing was seen in the stored episodes, however it was thought the inappropriate shocks were occurring due to the patient's high heart rate.Approximately one week later the patient has another inappropriate shock for af.The patient's medication was adjusted and the s-icd shock zones were reprogrammed.During the recent interrogation a concern over electrode integrity was discussed as one of the sensing vectors appeared to be flat.Ts suggested an x-ray and additional testing.It was further noted the patient is a recreational drug user which may be contributing to the arrhythmias.The field representative indicated that an x-ray was taken, but the results were unknown.The patient was scheduled to follow up at a different clinic.That field representative noted the patient had to cancel their initial follow up appointment due to weather.The appointment was rescheduled.The s-icd and electrode remain in service and no adverse patient effects were reported.Additional information was received that the remote home monitoring system issued an alert for high out of range shock impedance measurements on the electrode.Boston scientific technical services (ts) was consulted and discussed that the shock impedance was greater than 400 ohms during the weekly test and was an acute change.Review of the primary sensing vector, which was currently programmed, found many atrial fibrillation (af) episodes, some with noise and some without noise.The noise was deemed similar to myopotential, but had a different morphology.Ts noted that the patient should be considered unprotected at this point and suggested scheduling an in-clinic appointment to evaluate with sensing vectors and take x-rays.The patient was brought into the clinic for testing where they were unable to reproduce the noise.The shock impedance was consistently greater than 200 ohms.The alternate sensing vector was noted to be flat, but primary and secondary vectors had appropriate sensing.The patient does not have sternal wires and the electrode header x-ray appeared to confirm full electrode insertion into the header of the subcutaneous implantable cardioverter defibrillator (s-icd).Ts reviewed the x-ray and noted a possible 90 degree bend of the electrode as it comes out of the header of the s-icd.The electrode appeared to have no slack and ts recommended an electrode revision.The clinician called back later and stated that radiology produced an enhanced x-ray which showed the distal portion of the electrode is fractured and separated by one cm along the sternum, not near the header.This was determined to be the likely cause of the stored episodes and high impedance measurements.The field representative will attempt to obtain additional information from the clinic for resolution of the electrode issue.If additional information becomes available the report will be updated at that time.The electrode remains in service at this time.Additional information was received that a revision procedure was performed where the electrode was confirmed to be fractured and separated with visual inspection.The electrode was explanted.The s-icd was also explanted during the revision procedure as the patient was implanted with a transvenous implantable cardioverter defibrillator (icd) system.No additional adverse patient effects were reported.In december 2020, boston scientific issued an advisory notification regarding the potential for emblem s-icd subcutaneous electrodes to exhibit a lead body fracture just distal to the proximal sense ring.This electrode is a part of the advisory population.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this electrode was thoroughly inspected and analyzed.Resistance testing confirmed the electrode was fractured and visual examination determined the fracture was located approximately 32.5 cm from terminal pin, in the area distal to the sensing electrode.The clinical observations from the field were determined to likely be the result of the fracture.

• Brand Name: EMBLEM S-ICD
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11369755
• MDR Text Key: 233248375
• Report Number: 2124215-2021-04350
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526599200
• UDI-Public: 00802526599200
• Combination Product (y/n): N
• PMA/PMN Number: P110042/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/10/2021
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 169573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 04/06/2021; 04/14/2021; 06/09/2021
• Supplement Dates FDA Received: 07/16/2021; 07/18/2021; 07/22/2021
• Removal/Correction Number: Z-0879-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 56 YR