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

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	08/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
This supplemental is being submitted to correct the tab b.Adverse event/product prob section for the adverse event/product problem.The codes should be product problem and serious injury.The outcomes attrib to adv event code should be hospitalization - initial or prolonged.This supplemental report is being filed to provide additional information that the product has been explanted and returned.There were no additional adverse patient effects.It was reported that this device could not be interrogated.Magnet application over the device did not yield tones.The device has been implanted greater than ten years and the patient has not been compliant with follow-ups.Technical services suspects the battery is dead and discussed some options, such as a life vest.There were no adverse patient effects.The device remains implanted.
Additional Manufacturer Narrative
This supplemental is being submitted to correct the tab b.Adverse event/product prob section for the adverse event/product problem.The codes should be product problem and serious injury.The outcomes attrib to adv event code should be hospitalization - initial or prolonged.

• 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: 50254248
• Report Number: 2124215-2026-43690
• Device Sequence Number: 10193707
• Product Code: LWS
• UDI-Device Identifier: 00802526544101
• UDI-Public: (01)00802526544101(17)180412
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 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): 09/17/2026

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: 04/12/2018
• Device Model Number: A209
• Device Catalogue Number: A209
• Device Lot Number: 115567
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Supplement Date Received by Manufacturer: 08/26/2026; 08/26/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/14/2026; 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2016
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 28 YR
• Patient Sex: Male