MAUDE Adverse Event Report: OSCOR INC EMBLEM S-ICD; IMPLANTABLE LEAD

Model Number 3401

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581)

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

Event Date 03/20/2024

Event Type  malfunction  

Event Description

It was reported that the subcutaneous implantable cardioverter defibrillator (s-icd) delivered a potentially inappropriate shock due to oversensing and premature ventricular contraction (pvc).Technical services (ts) was contacted, and ts discussed that therapy may have been clinically appropriate but just under rate cut-off based on programming.The shock slowed the rhythm to a slow ventricular tachycardia (vt).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): OSCOR INC; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer (Section G): BOSTON SCIENTIFIC; 4100 hamline ave n; st. paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18976162
• MDR Text Key: 338577065
• Report Number: 2124215-2024-18059
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526585968
• UDI-Public: 00802526585968
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110042/S043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2019
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A143079
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2017
• 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: 20 YR
• Patient Sex: Male