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

Model Number 3501

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917); Material Integrity Problem (2978)

Patient Problem Electric Shock (2554)

Event Date 12/09/2023

Event Type  Injury  

Event Description

It was reported that a single inappropriate shock from this subcutaneous implantable cardioverter defibrillator (s-icd) was delivered due to over-sensed noise.The patient was subsequently evaluated in-clinic, where provocative maneuvers and diagnostic imaging were performed.The noise was found to be reproducible in both the primary and alternate sensing vectors.As a result, the physician elected to reprogram the s-icd to the secondary sensing vector pending a potential system revision.These details were forwarded to boston scientific technical services (ts) for review and it was discussed that the recent inappropriate episode was likely delivered due to sense node b artifacts.Additionally, there was another inappropriate shock in 2020 delivered due to over-sensed myopotential noise.Ts reviewed the diagnostic imaging results and it was confirmed that the s-icd connection was appropriate.However, there was a sharp kink near the device header that likely exhibited stress on the electrode body.Despite this, ts confirmed that the system was functioning appropriately in the newly programmed secondary sensing vector.At this time, it is unknown if the physician will proceed with a surgical revision procedure.The s-icd system remains implanted and in-service.No additional adverse patient effects were reported.

Event Description

It was reported that a single inappropriate shock from this subcutaneous implantable cardioverter defibrillator (s-icd) was delivered due to over-sensed noise.The patient was subsequently evaluated in-clinic, where provocative maneuvers and diagnostic imaging were performed.The noise was found to be reproducible in multiple sensing vectors.As a result, the physician elected to reprogram the s-icd to the secondary sensing vector pending a potential system revision.These details were forwarded to boston scientific technical services (ts) for review and it was discussed that the recent inappropriate episode was likely delivered due to sense node b artifacts.Additionally, there was another inappropriate shock in 2020 delivered due to over-sensed myopotential noise.Ts reviewed the diagnostic imaging results and it was confirmed that the s-icd connection was appropriate.However, there was a sharp kink near the device header that likely exhibited stress on the electrode body.Despite this, ts confirmed that the system was functioning appropriately in the newly programmed secondary sensing vector.The patient elected to get a second opinion, and thus, no surgical intervention is anticipated in the near future.Recently, it was clarified that the device was actually programmed to the primary sensing vector.An inquiry to ts was made requesting a current review of the remote data.It was confirmed that following the recent reprogramming, there had not been any inappropriate episodes and the sensing appeared appropriate.However, it was recommended to perform integrity testing at the next regular follow-up appointment to ensure proper electrode function.At this time, the s-icd system remains implanted and in-service.No additional adverse patient effects were reported.

Event Description

It was reported that a single inappropriate shock from this subcutaneous implantable cardioverter defibrillator (s-icd) was delivered due to over-sensed noise.The patient was subsequently evaluated in-clinic, where provocative maneuvers and diagnostic imaging were performed.The noise was found to be reproducible in both the primary and alternate sensing vectors.As a result, the physician elected to reprogram the s-icd to the secondary sensing vector pending a potential system revision.These details were forwarded to boston scientific technical services (ts) for review and it was discussed that the recent inappropriate episode was likely delivered due to sense node b artifacts.Additionally, there was another inappropriate shock in 2020 delivered due to over-sensed myopotential noise.Ts reviewed the diagnostic imaging results and it was confirmed that the s-icd connection was appropriate.However, there was a sharp kink near the device header that likely exhibited stress on the electrode body.Despite this, ts confirmed that the system was functioning appropriately in the newly programmed secondary sensing vector.The patient elected to get a second opinion, and thus, no surgical intervention is anticipated in the near future.The s-icd system remains implanted and in-service.No additional adverse patient effects were reported.

Event Description

It was reported that a single inappropriate shock from this subcutaneous implantable cardioverter defibrillator (s-icd) was delivered due to over-sensed noise.The patient was subsequently evaluated in-clinic, where provocative maneuvers and diagnostic imaging were performed.The noise was found to be reproducible in multiple sensing vectors.As a result, the physician elected to reprogram the s-icd to the secondary sensing vector pending a potential system revision.These details were forwarded to boston scientific technical services (ts) for review and it was discussed that the recent inappropriate episode was likely delivered due to sense node b artifacts.Additionally, there was another inappropriate shock in 2020 delivered due to over-sensed myopotential noise.Ts reviewed the diagnostic imaging results and it was confirmed that the s-icd connection was appropriate.However, there was a sharp kink near the device header that likely exhibited stress on the electrode body.Despite this, ts confirmed that the system was functioning appropriately in the newly programmed secondary sensing vector.The patient elected to get a second opinion, and thus, no surgical intervention is anticipated in the near future.Recently, it was clarified that the device was actually programmed to the primary sensing vector.An inquiry to ts was made requesting a current review of the remote data.It was confirmed that following the recent reprogramming, there had not been any inappropriate episodes and the sensing appeared appropriate.However, it was recommended to perform integrity testing at the next regular follow-up appointment to ensure proper electrode function.The physician subsequently explanted and replaced the s-icd system to resolve the event and no additional adverse patient effects were reported.The explanted system is expected to be returned for analysis, but has not yet been received.

Manufacturer Narrative

The returned electrode was thoroughly inspected and analyzed.Resistance tests were completed to assess electrical performance and inner insulation integrity.Measurements throughout these tests were within normal limits.However, visual inspections of the electrode body near the device header revealed a sharp kink at approximately 25-35 mm, and there was accompanying surface abrasion located at approximately 25 mm.Additionally, it was noted that a suture was tied tight onto the electrode body just distal of the terminal end.This damage was considered to be induced damage that is not indicative of a product defect or malfunction.Therefore, laboratory analysis did not identify any electrode characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported that a single inappropriate shock from this subcutaneous implantable cardioverter defibrillator (s-icd) was delivered due to over-sensed noise.The patient was subsequently evaluated in-clinic, where provocative maneuvers and diagnostic imaging were performed.The noise was found to be reproducible in multiple sensing vectors.As a result, the physician elected to reprogram the s-icd to the secondary sensing vector pending a potential system revision.These details were forwarded to boston scientific technical services (ts) for review and it was discussed that the recent inappropriate episode was likely delivered due to sense node b artifacts.Additionally, there was another inappropriate shock in 2020 delivered due to over-sensed myopotential noise.Ts reviewed the diagnostic imaging results and it was confirmed that the s-icd connection was appropriate.However, there was a sharp kink near the device header that likely exhibited stress on the electrode body.Despite this, ts confirmed that the system was functioning appropriately in the newly programmed secondary sensing vector.The patient elected to get a second opinion, and thus, no surgical intervention is anticipated in the near future.Recently, it was clarified that the device was actually programmed to the primary sensing vector.An inquiry to ts was made requesting a current review of the remote data.It was confirmed that following the recent reprogramming, there had not been any inappropriate episodes and the sensing appeared appropriate.However, it was recommended to perform integrity testing at the next regular follow-up appointment to ensure proper electrode function.The physician subsequently explanted and replaced the s-icd system to resolve the event and no additional adverse patient effects were reported.The explanted system was returned for analysis.

• Brand Name: EMBLEM S-ICD ELECTRODE
• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18387792
• MDR Text Key: 331287681
• Report Number: 2124215-2023-73472
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P110042/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/11/2024

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: 09/18/2020
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 129849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 01/02/2024; 01/23/2024; 03/08/2024
• Supplement Dates FDA Received: 01/08/2024; 02/08/2024; 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention