MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM? S-ICD; Implantable Cardioverter Defibrillator (Non-Crt)

Model Number	A209
Medical Device Problem Codes	High impedance (1291); Impedance Problem (2950); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) and electrode exhibited elevated system impedance measurement of 120 ohms.A 10j shock was performed, and a delivered shock impedance of 124 ohms was noted.It was noted that the s-icd was scheduled for a routine battery replacement, and it was not possible to retrieve device data because the s-icd was at end of life (eol).Technical services (ts) reviewed next steps for the electrode included surgical revision or defibrillation threshold (dft) testing.If dfts were unsuccessful, the options were to surgically revise or consider a different implantable system, as it was possible this may be a higher dft patient.Fluoroscopic imaging may also be used to look for adipose tissue.Additional information received reported that the electrode had been implanted in a suboptimal location, to the left of the sternum.Subsequently, the s-icd was explanted, the electrode was surgically abandoned, and a new s-icd system was implanted.No additional adverse patient effects were reported.The s-icd was retained by the hospital and will not be returned.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: EMBLEM? S-ICD
• Common Device Name: Implantable Cardioverter Defibrillator (Non-Crt)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel E91 T 862; EI E91 T862
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50748335
• Report Number: 2124215-2026-48848
• Device Sequence Number: 12897291
• Product Code: LWS
• UDI-Device Identifier: 00802526544101
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P110042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/12/2026

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: 08/04/2017
• Device Model Number: A209
• Device Catalogue Number: A209
• Device Lot Number: 106805
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 08/04/2015
• 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: Required Intervention; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Male