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

Model Number	A209
Medical Device Problem Code	Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this device had not been interrogated in over 3 years.Interrogation was being performed now and the caller stated it was taking a long time and the programmer was stuck on the progress bar at 100% complete.A boston scientific technical services consultant instructed the caller to restart the programmer which resulted in successful stated interrogation and update.No adverse patient effects were reported.It was reported that this device was subsequently explanted for normal battery depletion.The product is being evaluated in our post market quality assurance laboratory.This report will be updated when evaluation is complete.
Additional Manufacturer Narrative
This explanted device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.High power visual inspection of the header revealed no anomalies.Telemetry was normal upon return and a full memory download was performed and completed.After chilling the device, rf telemetry could not be established, suggesting a potential intermittent, temperature-dependent issue within the rf circuitry.Device connected to iva (implant verification assistant) and a diagnostic download was performed and completed normally.There were no suspicious system errors or resets and the v2p2 counts were normal.The device communicated normally with the emblem software on the 3300 programmer and the progress bar successfully completed normally.Additional testing was conducted to further evaluate the intermittent difficulty encountered with establishing telemetry with this device; the rf wake-up periods were monitored while the device was subjected to varying temperatures.Although there were wake-up periods during this testing that were observed to be within the operational threshold (at least 1.8 milliseconds), most of the wake-up periods measured above room temperature were less than the operational threshold.This device behavior is consistent with a rare, shortened telemetry wake-up pulse behavior associated with a telemetry component (oscillating crystal) within the rf circuit, resulting in an intermittent inability to interrogate the s-icd.Although this behavior resulted in the observed interrogation difficulties, please note that tachycardia therapy remained available to the patient.

• 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 ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 23423761
• Report Number: 2124215-2025-78038
• Device Sequence Number: 13211071
• Product Code: LWS
• UDI-Device Identifier: 00802526544101
• UDI-Public: (01)00802526544101(17)170901
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2025

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: Other
• Device Expiration Date: 09/01/2017
• Device Model Number: A209
• Device Catalogue Number: A209
• Device Lot Number: 107954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2015
• 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
• Patient Age: 42 YR
• Patient Sex: Female