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

Model Number	3401
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) system had an increase in its system impedance measurements.Technical services (ts) was consulted and discussed stored data, with adipose tissues suspected as the cause in the increase of the measurements.The system impedance measurements had increase but they were still within range.At a later date, an electrode revision was performed and a new electrode was implanted.The system impedance was still elevated, but it was still within range.A defibrillation threshold (dft) test was performed and the shock impedance measurement was within range.Ts discussed troubleshooting options and further examination.At a later date, this electrode was explanted.A new electrode was implanted.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) system had an increase in its system impedance measurements.Technical services (ts) was consulted and discussed stored data, with adipose tissues suspected as the cause in the increase of the measurements.The system impedance measurements had increase but they were still within range.At a later date, an electrode revision was performed and a new electrode was implanted.The system impedance was still elevated, but it was still within range.A defibrillation threshold (dft) test was performed and the shock impedance measurement was within range.Ts discussed troubleshooting options and further examination.At a later date, this electrode was explanted.A new electrode was implanted.No additional adverse patient effects were reported.This device has been returned and analyzed.
Additional Manufacturer Narrative
The returned electrode was thoroughly inspected and analyzed.Resistance tests were completed to assess electrical performance and inner insulation integrity.Measurements throughout these tests were within normal limits.Laboratory analysis did not identify any electrode characteristics that would have caused or contributed to the reported clinical observations.The manufacturing process for this electrode model included extensive inspections to ensure that the finished product met specifications prior to distribution, including validation of sterility and a series of visual, functional, and electrical tests.There is no indication that the referenced event was related to the manufacturing process.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.

• 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: 24148827
• Report Number: 2124215-2026-04097
• Device Sequence Number: 13011299
• Product Code: LWS
• UDI-Device Identifier: 00802526585968
• UDI-Public: (01)00802526585968(17)181001
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• 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): 03/31/2026

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: 10/01/2018
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A138209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male