MAUDE Adverse Event Report: OSCOR INC EMBLEM S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	3401
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	01/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had an inappropriate shock due to oversensing of electro-mechanical noise.The patent was using a foot plate for neuropathy at the time of the shock.Also, the low energy shock impedance measurements have been in the 130-ohm range.This is high but within normal limits.Technical services discussed the findings with the caller.There were no additional adverse patient effects.The system remains implanted.
Additional Manufacturer Narrative
The device was not returned for analysis as it remains implanted; therefore, a technical analysis could not be performed.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of inappropriate shock 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.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
This supplemental report is being filed to provide additional information for the h11 section of tab h.Device manufacturers only.It was reported that the patient had an inappropriate shock due to oversensing of electro-mechanical noise.The patent was using a foot plate for neuropathy at the time of the shock.Also, the low energy shock impedance measurements have been in the 130-ohm range.This is high but within normal limits.Technical services discussed the findings with the caller.There were no additional adverse patient effects.The system remains implanted.

• 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; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24390891
• Report Number: 2124215-2026-09346
• Device Sequence Number: 10504293
• Product Code: LWS
• UDI-Device Identifier: 00802526575600
• UDI-Public: (01)00802526575600(17)180501
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P110042/S043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/01/2018
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A133197
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 04/25/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/27/2026
• 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
• Patient Age: 66 YR
• Patient Sex: Female