MAUDE Adverse Event Report: OSCOR INC EMBLEM S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	3401
Medical Device Problem Codes	High impedance (1291); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581); Under-Sensing (1661); Migration (4003)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) delivered an inappropriate electric shock due to oversensing.Low amplitude and undersensing was also determined.A x ray was performed and it was noted that the electrode was moved and the s-icd was in elective replacement indicator (eri).It was also noted that the shock impedance was high.The plan is replacing the entire system.Subsequently, a revision procedure was performed and the electrode was explanted and replaced.While, the s-icd was replaced due to normal battery depletion.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
With the available information, boston scientific concluded that the clinical observation of migration is a known inherent risk of the product and is noted within the instructions for use (ifu), as well as the product's risk documentation.A risk review was completed and confirmed that the event of migration 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.This migration has been observed with this product previously and is a known inherent risk associated with its use and is documented in the labeling of the product.This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) delivered an inappropriate electric shock due to oversensing.Low amplitude and undersensing was also determined.A x ray was performed and it was noted that the electrode was moved and the s-icd was in elective replacement indicator (eri).It was also noted that the shock impedance was high.The plan is replacing the entire system.Subsequently, a revision procedure was performed and the electrode was explanted and replaced.While, the s-icd was replaced due to normal battery depletion.No additional adverse patient effects were reported.

• Brand Name: EMBLEM S-ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): OSCOR INC; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; saint paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24513016
• Report Number: 2124215-2026-11979
• Device Sequence Number: 16028109
• Product Code: LWS
• UDI-Device Identifier: 00802526585968
• UDI-Public: (01)00802526585968(17)190301
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/29/2026

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: 03/01/2019
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A144927
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/29/2026
• Date Device Manufactured: 03/16/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male