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

Model Number	3401
Medical Device Problem Code	Failure to Convert Rhythm (1540)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) system delivered two shocks as appropriate therapy that did not convert the patient's rhythm, with the rhythm terminating on its own.Technical services (ts) was consulted and discussed stored data, with further in clinic examination recommended to confirm system placement.X-ray imaging was performed and based on it; it was suspected that the electrode had suboptimal position.At a later date, this s-icd system was explanted and a new transvenous system implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
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.A risk review was completed and confirmed that the event of difficulty converting rhythm (ambulatory) was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.The device was not returned for analysis; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) system delivered two shocks as appropriate therapy that did not convert the patients rhythm, with the rhythm terminating on its own.Technical services (ts) was consulted and discussed stored data, with further in clinic examination recommended to confirm system placement.X-ray imaging was performed and based on it, it was suspected that the electrode had suboptimal position.At a later date, this s-icd system was explanted and a new transvenous system implanted.No additional 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
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24747199
• Report Number: 2124215-2026-17669
• Device Sequence Number: 8708010
• Product Code: LWS
• UDI-Device Identifier: 00802526575600
• UDI-Public: (01)00802526575600(17)171101
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P110042/S043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 05/28/2026

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: 11/01/2017
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A129021
• 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: 03/11/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/28/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 28 YR
• Patient Sex: Male