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

Model Number	3401
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during an office follow-up, the low energy shock impedance was varying between 165 and 175 ohms.Technical services reviewed the device downloaded data.The most likely consideration is an electrode coil in adipose tissue.The impedances are high but within normal limits.Technical services discussed the data with the clinic.The doctor elected to explant and replace the electrode with a new one.There were no additional adverse patient effects.
Additional Manufacturer Narrative
This electrode was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.Resistance testing found the electrode was not electrically continuous.An x-ray confirmed that the high voltage cables have fractured in and around the area approximately 33mm from the terminal end.The fracture characteristics appeared consistent with cyclic fatigue.Analysis has determined that in certain tight bend conditions of the s-icd lead, highly localized stresses are created that, when exposed to repeated movement, may lead to a fatigue fracture.
Event or Problem Description
This supplemental report is being filed to provide additional information regarding product analysis.It was reported that, during an office follow-up, the low energy shock impedance was varying between 165 and 175 ohms.Technical services reviewed the device downloaded data.The most likely consideration is an electrode coil in adipose tissue.The impedances are high but within normal limits.Technical services discussed the data with the clinic.The doctor elected to explant and replace the electrode with a new one.There were no additional adverse patient effects.

• 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 55110
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 23783187
• Report Number: 2124215-2025-90464
• Device Sequence Number: 5129256
• Product Code: LWS
• UDI-Device Identifier: 00802526585968
• UDI-Public: (01)00802526585968(17)190601
• 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: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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: A147866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0879-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male