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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient received two inappropriate shocks from this subcutaneous implantable cardioverter defibrillator (sicd).Boston scientific (bsc) technical services (ts) was contacted for episode review.Ts inquired as to what vector the device was programmed to and this information was unknown.The consultant stated the presentation appears to be similar to devices programmed to secondary vector that have a seal plug issue and recommended reprogramming from secondary vector to primary vector.However, if it is discovered that primary was the programmed vector, then this could indicate air at the sensing electrode and the vector should be reprogrammed to secondary.The bsc local area representative will investigate further and program to the vector opposite of what the current programming is.The system remains in service and no additional adverse patient effects were reported.Additional information was received that this device was explanted and returned over five years after the initial clinical observations were reported.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product is being evaluated in our post market quality assurance laboratory.This report will be updated when investigation is complete.

• 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 Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50934655
• Report Number: 2124215-2026-51716
• Device Sequence Number: 9589303
• Product Code: LWS
• UDI-Device Identifier: 00802526585968
• UDI-Public: (01)00802526585968(17)181201
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 12/01/2018
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A140474
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/29/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Male