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

Model Number 3501

Device Problems Signal Artifact/Noise (1036); Fracture (1260); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Material Integrity Problem (2978)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 04/23/2023

Event Type  Injury  

Event Description

It was reported that the patient received an inappropriate shock from the subcutaneous implantable cardioverter defibrillator (s-icd) while riding a bicycle.The shock was determined to be due to oversensing noise.The physician was concerned over an electrode integrity issue as the noise was able to be replicated during in office testing.Technical services (ts) was consulted to review and noted the noise appeared to be related to myopotential noise.Ts observed the noise may not indicate an electrode issue and suggested performing additional testing and x-ray imaging.Additional information was received that a revision procedure was performed where upon removal of the electrode, the suture sleeve was observed to be cut off of the electrode.Due to concern over a fractured electrode, the lead was removed.A new electrode was implanted; however, the patient did not pass screening in any vector.It was noted that the sensing vectors did not pass with the previous electrode during testing at the revision.Subsequently the entire s-icd system was explanted.Further review of the stored data noted an episode from 10 months earlier with myopotential oversensing leading to an untreated episode.No additional adverse effects were reported.

Manufacturer Narrative

This product has not been returned to date.If returned analysis will be performed and this report will be updated.

Event Description

It was reported that the patient received an inappropriate shock from the subcutaneous implantable cardioverter defibrillator (s-icd) while riding a bicycle.The shock was determined to be due to oversensing noise.The physician was concerned over an electrode integrity issue as the noise was able to be replicated during in office testing.Technical services (ts) was consulted to review and noted the noise appeared to be related to myopotential noise.Ts observed the noise may not indicate an electrode issue and suggested performing additional testing and x-ray imaging.Additional information was received that a revision procedure was performed where upon removal of the electrode, the suture sleeve was observed to be cut off of the electrode.Due to concern over a fractured electrode, the lead was removed.A new electrode was implanted; however, the patient did not pass screening in any vector.It was noted that the sensing vectors did not pass with the previous electrode during testing at the revision.Subsequently the entire s-icd system was explanted.Further review of the stored data noted an episode from 10 months earlier with myopotential oversensing leading to an untreated episode.The field representative noted that the clinic did not have any concerns over a device related issue regarding the noise.No additional adverse effects were reported.

Manufacturer Narrative

This product has not been returned to date.If returned analysis will be performed and this report will be updated.The returned electrode was returned in two segments.It 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.Microscopic inspections of the terminal pin assembly and electrode body found no anomalies.Laboratory analysis did not identify any electrode characteristics that would have caused or contributed to the reported clinical observations.

• Brand Name: EMBLEM 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18885801
• MDR Text Key: 337436282
• Report Number: 2124215-2024-14859
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110042/S077
• 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
• Report Date: 05/16/2024

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 Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 230816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization