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

Model Number	3401
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) system delivered an inappropriate shock due to oversensing of noise.Subsequently, this patient was admitted to the hospital where the noise could be reproduced with arm movements; therefore, tachycardia therapy was deactivated at this time.It was noted that further testing will be conducted to ascertain if replacement or reprogramming is necessary.It was also stated that the signal amplitude had been decreasing over the past six months.Technical services (ts) analyzed device episode data and confirmed that the inappropriate shock was due to oversensing of myopotential noise and a decrease in r-wave amplitudes.This occurred in the secondary vector.No adverse patient effects were reported.Currently, this s-icd system remains in service.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) system delivered an inappropriate shock due to oversensing of noise.Subsequently, this patient was admitted to the hospital where the noise could be reproduced with arm movements; therefore, tachycardia therapy was deactivated at this time.It was noted that further testing will be conducted to ascertain if replacement or reprogramming is necessary.It was also stated that the signal amplitude had been decreasing over the past six months.Technical services (ts) analyzed device episode data and confirmed that the inappropriate shock was due to oversensing of myopotential noise and a decrease in r-wave amplitudes.This occurred in the secondary vector.No adverse patient effects were reported.Currently, this s-icd system remains in service.
Additional Manufacturer Narrative
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.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.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.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) system delivered an inappropriate shock due to oversensing of noise.Subsequently, this patient was admitted to the hospital where the noise could be reproduced with arm movements; therefore, tachycardia therapy was deactivated at this time.It was noted that further testing will be conducted to ascertain if replacement or reprogramming is necessary.It was also stated that the signal amplitude had been decreasing over the past six months.Technical services (ts) analyzed device episode data and confirmed that the inappropriate shock was due to oversensing of myopotential noise and a decrease in r-wave amplitudes.This occurred in the secondary vector.No adverse patient effects were reported.Currently, this s-icd system remains in service.According to additional information, this s-icd system has been explanted.A new s-icd system was placed at this time.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
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.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.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.

• Brand Name: EMBLEM S-ICD
• Common Device Name: IMPLANTABLE ELECTRODE
• Manufacturer (Section D): OSCOR INC; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24377831
• Report Number: 2124215-2026-09056
• Device Sequence Number: 4941602
• Product Code: LWS
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P110042/S043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 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: 04/01/2019
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A145833
• Was Device Available for Evaluation?: No
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 03/19/2026; 04/29/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/19/2026; 04/29/2026
• Date Device Manufactured: 04/14/2017
• 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: 76 YR
• Patient Sex: Unknown