MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM MRI S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number A219

Device Problems Signal Artifact/Noise (1036); Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574); Telemetry Discrepancy (1629); Low impedance (2285)

Patient Problems Device Overstimulation of Tissue (1991); Electric Shock (2554)

Event Date 02/26/2022

Event Type  Injury  

Manufacturer Narrative

This report will be updated when additional information is received.

Event Description

It was reported that the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) was feeling small discharges from the device at the same time once a week.This began after the patient received a shock from the device that was deemed inappropriate due to aberrantly conducted atrial fibrillation (af).However, the episode s-ecg showed a rather sudden change in signal morphology with a sudden change in signal polarity and stability of the rate that was more consistent with a ventricular tachycardia (vt), and the shock did terminate the rhythm.Technical services reviewed the available device data and found the shock impedance for the delivered shock was low, out-of-range at 5 ohms, indicating a shorted condition.The episode showed suspicious signals after the shock delivery, indicating the device was likely damaged during the shock.The sensation the patient was feeling was likely the device's weekly shock impedance check.Technical services recommended admitting the patient to the hospital and replacing the device and thoroughly evaluating the electrode.It was reported the patient was not seen in the clinic or admitted to the hospital, and a device replacement was planned for at a later date.The patient has been followed for 26 years and was implanted for primary prevention, with no history of vt/vf.Technical services discussed it was not possible to stop the weekly impedance check, but the physician could deactivate device therapy to avoid potential shock delivery.In any case, the patient is considered unprotected and immediate device replacement was recommended.No adverse patient effects were reported.It was later reported that the patient was seen in the clinic and therapy was deactivated.Additionally, a cardioversion was performed for the patient's atrial fibrillation (af).A device replacement procedure was planned for (b)(6).The patient was anxious about having therapy turned off and returned to the clinic the following week requesting that therapy be programmed back on.However, the device was not able to be interrogated with several programmers and therapy remains off.

Manufacturer Narrative

This report will be updated when additional information is received.The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.

Event Description

It was reported that the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) was feeling small discharges from the device at the same time once a week.This began after the patient received a shock from the device that was deemed inappropriate due to aberrantly conducted atrial fibrillation (af).However, the episode s-ecg showed a rather sudden change in signal morphology with a sudden change in signal polarity and stability of the rate that was more consistent with a ventricular tachycardia (vt), and the shock did terminate the rhythm.Technical services reviewed the available device data and found the shock impedance for the delivered shock was low, out-of-range at 5 ohms, indicating a shorted condition.The episode showed suspicious signals after the shock delivery, indicating the device was likely damaged during the shock.The sensation the patient was feeling was likely the device's weekly shock impedance check.Technical services recommended admitting the patient to the hospital and replacing the device and thoroughly evaluating the electrode.It was reported the patient was not seen in the clinic or admitted to the hospital, and a device replacement was planned for at a later date.The patient has been followed for 26 years and was implanted for primary prevention, with no history of vt/vf.Technical services discussed it was not possible to stop the weekly impedance check, but the physician could deactivate device therapy to avoid potential shock delivery.In any case, the patient is considered unprotected and immediate device replacement was recommended.No adverse patient effects were reported.It was later reported that the patient was seen in the clinic and therapy was deactivated.Additionally, a cardioversion was performed for the patient's atrial fibrillation (af).A device replacement procedure was planned for 12 may.The patient was anxious about having therapy turned off and returned to the clinic the following week requesting that therapy be programmed back on.However, the device was not able to be interrogated with several programmers and therapy remains off.The device and electrode were explanted and replaced on 12 may, as planned.The device was again not able to be interrogated.During the procedure, obvious damage was noted on the electrode's insulation near the header of the device.No additional adverse patient effects were reported.The explanted products were expected to be returned for analysis.

Manufacturer Narrative

This report will be updated when additional information is received.The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.This device was thoroughly inspected and analyzed upon receipt.Visual examination noted two arc marks on the exterior case.It was verified the device could not be interrogated.An x-ray of the device noted damage to the internal high voltage capacitor flex component.This damage is consistent with the device being subjected to high energy, likely arced from the electrode.

Event Description

It was reported that the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) was feeling small discharges from the device at the same time once a week.This began after the patient received a shock from the device that was deemed inappropriate due to aberrantly conducted atrial fibrillation (af).However, the episode s-ecg showed a rather sudden change in signal morphology with a sudden change in signal polarity and stability of the rate that was more consistent with a ventricular tachycardia (vt), and the shock did terminate the rhythm.Technical services reviewed the available device data and found the shock impedance for the delivered shock was low, out-of-range at 5 ohms, indicating a shorted condition.The episode showed suspicious signals after the shock delivery, indicating the device was likely damaged during the shock.The sensation the patient was feeling was likely the device's weekly shock impedance check.Technical services recommended admitting the patient to the hospital and replacing the device and thoroughly evaluating the electrode.It was reported the patient was not seen in the clinic or admitted to the hospital, and a device replacement was planned for at a later date.The patient has been followed for 26 years and was implanted for primary prevention, with no history of vt/vf.Technical services discussed it was not possible to stop the weekly impedance check, but the physician could deactivate device therapy to avoid potential shock delivery.In any case, the patient is considered unprotected and immediate device replacement was recommended.No adverse patient effects were reported.It was later reported that the patient was seen in the clinic and therapy was deactivated.Additionally, a cardioversion was performed for the patient's atrial fibrillation (af).A device replacement procedure was planned for (b)(6).The patient was anxious about having therapy turned off and returned to the clinic the following week requesting that therapy be programmed back on.However, the device was not able to be interrogated with several programmers and therapy remains off.The device and electrode were explanted and replaced on (b)(6), as planned.The device was again not able to be interrogated.During the procedure, obvious damage was noted on the electrode's insulation near the header of the device.No additional adverse patient effects were reported.The explanted products were returned for analysis.

• Brand Name: EMBLEM MRI S-ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 14504463
• MDR Text Key: 292799122
• Report Number: 2124215-2022-14901
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526584404
• UDI-Public: 00802526584404
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P110042/S058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/07/2022
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 126559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization