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); Over-Sensing (1438); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2023

Event Type  Injury  

Event Description

It was reported that there were untreated episodes of oversensing noise stored in the subcutaneous implantable cardioverter defibrillator (s-icd) and technical services (ts) was consulted to review.Upon review ts noted the noise was saturated and discussed possible causes.Ts suggested further troubleshooting and x-ray images.During troubleshooting the noise was able to be reproduced in alternate and primary but not secondary when tapping on the header but not the can.X-ray images were sent into ts for review.Ts noted that electrode insertion appears normal and fully inserted and there is nothing unusual about the electrode presentation, such as no kinks or obvious fractures.Ts suggested to inquire if there was an injury or trauma to the area.Ts noted that this type of noise can affect therapy delivery and ineffective shock conversion therefore the patient should be considered as unprotected.Due to this ts suggested that the patient either be hospitalized or fitted for a life vest until the replacement.It was stated that therapy had been programmed off in the device.Ts also suggested that the entire system be explanted and if possible, the electrode explanted together with the device in one piece.The physician confirmed with the patient that there was no history of trauma, sport or repetitive activity.The physician was considering performing a maximum output manual shock test prior to determining if a revision for the electrode would be needed.This thought was due to the patient's slim stature and some difficulty tunnelling the electrode at the time of implant.A revision procedure took place a few days later.Prior to opening the pocket, the s-icd was manipulated in the pocket in all three sensing vectors with minimal mechanical noise artifact seen in alternate vector.A full output shock was given and yielded a 62 ohm impedance measurement.The pocket was then opened, and blood was observed in the header.A tug test was performed which showed good connection.Vigorous manual manipulation of the electrode and the header showed minimal noise in primary and alternate, however there was good sensing throughout.In the absence of any further evidence the physician made the decision to exchange the s-icd and leave the electrode in situ.This s-icd was explanted.With the new s-icd and chronic electrode further manual manipulation carried out with no noise seen.A defibrillation threshold (dft) test followed with a successful conversion of ventricular fibrillation (vf) at 65 jouse with an impedance of 67 ohms.Thus the new s-icd and chronic electrode remain in service.Additional information was received that following the procedure the physician requested data for the new s-icd and existing electrode to be analyzed and no signal saturation was observed.

Manufacturer Narrative

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

Event Description

It was reported that there were untreated episodes of oversensing noise stored in the subcutaneous implantable cardioverter defibrillator (s-icd) and technical services (ts) was consulted to review.Upon review ts noted the noise was saturated and discussed possible causes.Ts suggested further troubleshooting and x-ray images.During troubleshooting the noise was able to be reproduced in alternate and primary but not secondary when tapping on the header but not the can.X-ray images were sent into ts for review.Ts noted that electrode insertion appears normal and fully inserted and there is nothing unusual about the electrode presentation, such as no kinks or obvious fractures.Ts suggested to inquire if there was an injury or trauma to the area.Ts noted that this type of noise can affect therapy delivery and ineffective shock conversion therefore the patient should be considered as unprotected.Due to this ts suggested that the patient either be hospitalized or fitted for a life vest until the replacement.It was stated that therapy had been programmed off in the device.Ts also suggested that the entire system be explanted and if possible, the electrode explanted together with the device in one piece.The physician confirmed with the patient that there was no history of trauma, sport or repetitive activity.The physician was considering performing a maximum output manual shock test prior to determining if a revision for the electrode would be needed.This thought was due to the patient's slim stature and some difficulty tunnelling the electrode at the time of implant.A revision procedure took place a few days later.Prior to opening the pocket, the s-icd was manipulated in the pocket in all three sensing vectors with minimal mechanical noise artifact seen in alternate vector.A full output shock was given and yielded a 62 ohm impedance measurement.The pocket was then opened, and blood was observed in the header.A tug test was performed which showed good connection.Vigorous manual manipulation of the electrode and the header showed minimal noise in primary and alternate, however there was good sensing throughout.In the absence of any further evidence the physician made the decision to exchange the s-icd and leave the electrode in situ.This s-icd was explanted.With the new s-icd and chronic electrode further manual manipulation carried out with no noise seen.A defibrillation threshold (dft) test followed with a successful conversion of ventricular fibrillation (vf) at 65 jouse with an impedance of 67 ohms.Thus the new s-icd and chronic electrode remain in service.Additional information was received that following the procedure the physician requested data for the new s-icd and existing electrode to be analyzed and no signal saturation was observed.

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.The returned s-icd was thoroughly inspected and analyzed.The device was able to be interrogated and a memory download was performed successfully.The device was then exposed to simulated heart load conditions, and the defibrillation and sensing functions were tested.The device operated appropriately, according to its performance specifications with no out-of-range measurements or interruptions in therapy output.Although the s-icd and electrode operated appropriately in the laboratory setting, engineers suspect there may have been a problem with the electrode/s-icd interface, resulting in transient changes in the impedance pathway of the sensing vector that utilizes the proximal sensing electrode (sense b).These changes in the impedance pathway may have contributed to the noise, oversensing, and inappropriate shock noted in the field; however, a definitive cause of this sensing behavior has not been determined.

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.The returned s-icd was thoroughly inspected and analyzed.The device was able to be interrogated and a memory download was performed successfully.The device was then exposed to simulated heart load conditions, and the defibrillation and sensing functions were tested.The device operated appropriately, according to its performance specifications with no out-of-range measurements or interruptions in therapy output.Although the s-icd and electrode operated appropriately in the laboratory setting, engineers suspect there may have been a problem with the electrode/s-icd interface, resulting in transient changes in the impedance pathway of the sensing vector that utilizes the proximal sensing electrode (sense b).These changes in the impedance pathway may have contributed to the noise, oversensing, and inappropriate shock noted in the field; however, a definitive cause of this sensing behavior has not been determined.

Event Description

It was reported that there were untreated episodes of oversensing noise stored in the subcutaneous implantable cardioverter defibrillator (s-icd) and technical services (ts) was consulted to review.Upon review ts noted the noise was saturated and discussed possible causes.Ts suggested further troubleshooting and x-ray images.During troubleshooting the noise was able to be reproduced in alternate and primary but not secondary when tapping on the header but not the can.X-ray images were sent into ts for review.Ts noted that electrode insertion appears normal and fully inserted and there is nothing unusual about the electrode presentation, such as no kinks or obvious fractures.Ts suggested to inquire if there was an injury or trauma to the area.Ts noted that this type of noise can affect therapy delivery and ineffective shock conversion therefore the patient should be considered as unprotected.Due to this ts suggested that the patient either be hospitalized or fitted for a life vest until the replacement.It was stated that therapy had been programmed off in the device.Ts also suggested that the entire system be explanted and if possible, the electrode explanted together with the device in one piece.The physician confirmed with the patient that there was no history of trauma, sport or repetitive activity.The physician was considering performing a maximum output manual shock test prior to determining if a revision for the electrode would be needed.This thought was due to the patient's slim stature and some difficulty tunnelling the electrode at the time of implant.A revision procedure took place a few days later.Prior to opening the pocket, the s-icd was manipulated in the pocket in all three sensing vectors with minimal mechanical noise artifact seen in alternate vector.A full output shock was given and yielded a 62 ohm impedance measurement.The pocket was then opened, and blood was observed in the header.A tug test was performed which showed good connection.Vigorous manual manipulation of the electrode and the header showed minimal noise in primary and alternate, however there was good sensing throughout.In the absence of any further evidence the physician made the decision to exchange the s-icd and leave the electrode in situ.This s-icd was explanted.With the new s-icd and chronic electrode further manual manipulation carried out with no noise seen.A defibrillation threshold (dft) test followed with a successful conversion of ventricular fibrillation (vf) at 65 jouse with an impedance of 67 ohms.Thus the new s-icd and chronic electrode remain in service.Additional information was received that following the procedure the physician requested data for the new s-icd and existing electrode to be analyzed and no signal saturation was observed.Further information was received from the field representative with clarifying details regarding the situation.Below is a more clarified description of the occurrence.It was reported that the subcutaneous implantable cardioverter defibrillator (s-icd) recorded untreated episodes of oversensed noise.Technical services (ts) was consulted.Upon review of stored data, ts noted the noise was saturated and discussed possible causes.Ts suggested further troubleshooting and x-ray images.X-ray images were submitted to ts for review.Ts noted the electrode insertion appeared normal/full and there was nothing unusual about the electrode presentation (i.E., no kinks or obvious fractures).Ts suggesting inquiring with the patient whether there was an injury or trauma to the area and advised device replacement.It was confirmed with the patient that there was no history of trauma, sport, or repetitive activity.Prior to opening the pocket for the revision procedure, the s-icd was manipulated in the pocket in all three sensing vectors with minimal mechanical noise artifact seen, and only in the alternate vector.A full output shock was completed which yielded a 62 ohm impedance measurement.The pocket was then opened, and blood was observed in the header.A tug test was performed which confirmed a good connection between this s-icd and the electrode.Vigorous manual manipulation of the electrode and the header resulted in minimal noise in the primary and alternate vectors; however, sensing remained good throughout.In the absence of indication of a problem with the electrode, the decision was made to exchange the s-icd and leave the electrode in situ.A new s-icd was placed and testing with the chronic electrode resulted in no noise.A defibrillation threshold (dft) test was completed with successful conversion of ventricular fibrillation (vf) at 65 joules and a resulting shock impedance of 67 ohms.The new s-icd and chronic electrode remain in service.The explanted s-icd was 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: 16372490
• MDR Text Key: 309495247
• Report Number: 2124215-2023-06559
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 167419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 17 YR
• Patient Sex: Male