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

Model Number 3501

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)

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

Event Date 02/24/2024

Event Type  malfunction  

Event Description

It was reported that the subcutaneous implantable cardioverter defibrillator (s-icd) delivered an inappropriate shock due to electromagnetic interference (emi) oversensing.The s-icd system remains in service.No adverse patient effects were reported.

• Brand Name: EMBLEM S-ICD
• Type of Device: IMPLANTABLE LEAD
• 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: 18813450
• MDR Text Key: 337572939
• Report Number: 2124215-2024-12421
• Device Sequence Number: 1
• Product Code: LWS
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/13/2024
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 214820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• 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: 67 YR
• Patient Sex: Male