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

Model Number	3401
Medical Device Problem Codes	Failure to Convert Rhythm (1540); Unexpected Therapeutic Results (1631); Under-Sensing (1661)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	07/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient got a shock for a true ventricular tachycardia.The first shock accelerated the rhythm to ventricular fibrillation.Technical services reviewed the electrograms from the device.Following the shock that induced the ventricular fibrillation, there is significant undersensing which delays therapy.A second shock is eventually delivered after a full minute has elapsed.This shock converts the rhythm for a few seconds, but a third shock is required to eventually convert the arrhythmia completely.The doctor elected to explant and replace both the pulse generator and the electrode.There were no additional adverse patient effects.

• 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; cashel road; palm harbor FL 34683
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25860591
• Report Number: 2124215-2026-38526
• Device Sequence Number: 5532957
• Product Code: LWS
• UDI-Device Identifier: 00802526585968
• UDI-Public: (01)00802526585968(17)190101
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P110042/S043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/01/2019
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A142145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 07/17/2026
• Supplement Report FDA Received Date: 09/16/2026
• Date Device Manufactured: 01/18/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 43 YR
• Patient Sex: Male