MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM? S-ICD; SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD)

Model Number	A209
Medical Device Problem Codes	No Audible Alarm (1019); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this s-icd was thoroughly inspected and analyzed.A high current drain was detected.Detailed analysis confirmed the identified high current drain was a result of a compromised capacitor.This resulted in the observed premature battery depletion.It was determined that the capacitor was compromised due to the presence of excess hydrogen in the device case.Boston scientific issued a field safety notice regarding a subset of emblem devices that have a potential of exhibiting this behavior.This particular device is included in the emblem s-icd accelerated depletion advisory population.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) could not be interrogated.No tones were emitted when a magnet was placed over the device.Technical services (ts) discussed troubleshooting options including attempting with a new programmer.This device has been in service approximately nine years and will be replaced.No adverse patient effects were reported.Later this s-icd was explanted for normal battery depletion with successful replacement.

• Brand Name: EMBLEM? S-ICD
• Common Device Name: SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24068484
• Report Number: 2124215-2026-02444
• Device Sequence Number: 10386519
• Product Code: LWS
• UDI-Device Identifier: 00802526544101
• UDI-Public: (01)00802526544101(17)180524
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P110042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification,Recall
• Type of Report: Initial
• Report Date (Section B): 01/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/24/2018
• Device Model Number: A209
• Device Catalogue Number: A209
• Device Lot Number: 117083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2016
• 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-0935-2021
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male