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

Model Number	3401
Medical Device Problem Codes	High impedance (1291); Failure to Convert Rhythm (1540); Impedance Problem (2950); Migration (4003)
Health Effect - Clinical Code	Shock (2072)
Date of Event	01/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) exhibited high shock impedance measurements.Upon review, it was noted that the shock impedance at defibrillation threshold (dft) test implant was 75 ohms.Troubleshooting options were discussed and recommended.An x-ray was performed and it was observed that the electrode was moved.Then, a dft test was made and the s-icd failed in terminating ventricular fibrillation (vf).Subsequently, a revision procedure was performed and the electrode was explanted and replaced.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) exhibited high shock impedance measurements.Upon review, it was noted that the shock impedance at defibrillation threshold (dft) test implant was 75 ohms.Troubleshooting options were discussed and recommended.An x-ray was performed and it was observed that the electrode was moved.Then, a dft test was made and the s-icd failed in terminating ventricular fibrillation (vf).Subsequently, a revision procedure was performed and the electrode was explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.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.Microscopic inspections of the terminal pin assembly and electrode body found no anomalies.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.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.

• 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): Boston Scientific Corporation; saint paul MN 55112
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 24345686
• Report Number: 2124215-2026-08537
• Device Sequence Number: 10004917
• Product Code: LWS
• UDI-Device Identifier: 00802526585968
• UDI-Public: (01)00802526585968(17)190601
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P110042/S043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2026

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: 06/01/2019
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A147211
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/24/2026
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 05/29/2026; 08/31/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 06/19/2026; 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2017
• 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: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female