MAUDE Adverse Event Report: OSCOR INC EMBLEM S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 3401

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Material Integrity Problem (2978); No Apparent Adverse Event (3189); Migration (4003)

Patient Problems Shock from Patient Lead(s) (3162); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2024

Event Type  Injury  

Event Description

It was reported that this electrode was explanted due to a product performance issue after over six years of implant time.The entire subcutaneous system was successfully replaced with transvenous system.There were no additional adverse patient effects.

Event Description

This supplemental report is being filed to provide additional information that the patient had inappropriate shocks due to oversensing.The electrode had migrated and may have fractured.The entire subcutaneous system was successfully replaced with transvenous system.There were no additional adverse patient effects.It was reported that this device was explanted due to a product performance issue after over six years of implant time.The entire subcutaneous system was successfully replaced with transvenous system.There were no additional adverse patient effects.

• Brand Name: EMBLEM S-ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): OSCOR INC; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer (Section G): OSCOR, INCORPORATED; palm harbor FL 34683
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18851377
• MDR Text Key: 337070854
• Report Number: 2124215-2024-13862
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

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 Expiration Date: 02/01/2019
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A143116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA 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 Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female