MAUDE Adverse Event Report: Oscor Inc EMBLEM S-ICD; Implantable Cardioverter Defibrillator (Non-Crt)

Model Number	3401
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the system was being checked prior to the patient getting an mri.Upon interrogation, the programmer displayed a high impedance message.The low energy impedances were greater than 400 ohms.Also, the therapy was off.There was some programming done earlier and the auto setup feature had not been run.Now, the device could not be programmed to the mri mode due to the high impedances, and the likelihood that the auto set feature had not been completed.Technical services advised if the auto setup feature was run previously, and a high impedance is encountered, it can cause the therapy to turn off.The doctor elected to leave the therapy off and do the mri anyway.A review of the device downloaded data confirmed the impedances have been increasing since 2022.There were no adverse patient effects.The system remains implanted.

• Brand Name: EMBLEM S-ICD
• Common Device Name: Implantable Cardioverter Defibrillator (Non-Crt)
• Manufacturer (Section D): Oscor Inc; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer (Section G): Oscor, Incorporated; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50896346
• Report Number: 2124215-2026-51130
• Device Sequence Number: 16142847
• Product Code: LWS
• UDI-Device Identifier: 00802526585968
• UDI-Public: (01)00802526585968(17)181001
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P110042/S043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/01/2018
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A138459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/25/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male