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

Model Number 3401

Device Problem Low impedance (2285)

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

Event Date 04/18/2023

Event Type  malfunction  

Event Description

It was reported that this electrode exhibited low impedances out of range.The subcutaneous implantable cardioverter defibrillator (s-icd) was explanted due to normal battery depletion (nbd) and the electrode remains in service.Technical services (ts) explained that while the shock impedance is on the low end, it may choose to leave it as is or they could revise the generator to a more posterior position and, or move the electrode to the right.The caller indicated that the patient is very small, has a large heart, and has a micra among other considerations.No additional adverse patient effects were reported.

• Brand Name: EMBLEM S-ICD
• Type of Device: ELECTRODE
• Manufacturer (Section D): OSCOR INC; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer (Section G): BOSTON SCIENTIFIC; st paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16802049
• MDR Text Key: 313923466
• Report Number: 2124215-2023-19639
• 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: Physician
• Type of Report: Initial
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2017
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A129533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 47 YR
• Patient Sex: Female