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

Model Number 3501

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Erosion (1750); Unspecified Infection (1930)

Event Date 01/30/2023

Event Type  Injury  

Event Description

It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) was part of a system revision due to infection and abscess.This product was explanted.There were no additional adverse effects reported.

Manufacturer Narrative

This electrode was returned intact to our post market quality assurance laboratory.The visual inspection found no anomalies.Subsequently, testing was completed to assess lead electrical performance.Measurements throughout these tests were within normal limits.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) was part of a system revision due to infection and abscess.This product was explanted.There were no additional adverse effects reported.

• Brand Name: EMBLEM S-ICD
• Type of Device: IMPLANTABLE 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: 16399532
• MDR Text Key: 309791189
• Report Number: 2124215-2023-07387
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/06/2023
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 209883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2021
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 39 YR
• Patient Sex: Male