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

Model Number	3401
Medical Device Problem Codes	Failure to Convert Rhythm (1540); Failure to Read Input Signal (1581); Under-Sensing (1661); Low impedance (2285); Malposition of Device (2616); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) system recorded a system impedance measurement lower than 30 ohms.The signal in the primary sensing vector was noted to be small and with some undersensing noted.The patient required two shocks to be converted and in that episode the shock impedance was noted to be low within normal limits 30 ohms.A chest x ray showed the electrode was slightly bowed towards the s-icd.This s-icd system remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) system recorded a system impedance measurement lower than 30 ohms.The signal in the primary sensing vector was noted to be small and with some undersensing noted.The patient required two shocks to be converted and in that episode the shock impedance was noted to be low withing normal limits 30 ohms.A chest x ray showed the electrode was slightly bowed towards the s-icd.This s-icd system remains in service.No adverse patient effects were reported.

• Brand Name: EMBLEM S-ICD
• Common Device Name: ELECTRODE
• Manufacturer (Section D): OSCOR INC; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer (Section G): OSCOR INC; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 23560061
• Report Number: 2124215-2025-83178
• Device Sequence Number: 15992662
• Product Code: LWS
• UDI-Device Identifier: 00802526585968
• UDI-Public: (01)00802526585968(17)181101
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P110042/S043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: 11/01/2018
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A139862
• 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: 10/18/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/23/2025
• 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: Other
• Patient Age: 61 YR
• Patient Sex: Female