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

Model Number 3501

Device Problem High impedance (1291)

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

Event Date 05/22/2023

Event Type  malfunction  

Event Description

It was reported that this electrode exhibited high shock impedances out of range.An x ray was performed to compare initial electrode position to current position.There was no significant difference.The health care professional (hcp) will discuss with the physician to determine next steps.This electrode remains in service.No adverse patient effects were reported.

Event Description

It was reported that this electrode exhibited high shock impedances out of range.An x ray was performed to compare initial electrode position to current position.There was no significant difference.The health care professional (hcp) will discuss with the physician to determine next steps.Additional information was received which indicated that the high shock lead impedances cause could be adipose tissue or encapsulation of the coil.The hcp commented that patient has gained at least seventy pounds recently.Technical services (ts) discussed how this can certainly play a role in higher system impedance and it was recommended to perform an actual shock testing since there has not been a shock since implant and impedance has been rising.This electrode remains in service.No adverse patient effects were reported.

• Brand Name: EMBLEM S-ICD
• Type of Device: ELECTRODE
• 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: 17034876
• MDR Text Key: 316754289
• Report Number: 2124215-2023-27610
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526599200
• UDI-Public: 00802526599200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110042/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/10/2022
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 179537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Male