MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN? EL ICD DR; Implantable Cardioverter Defibrillator (ICD)

Model Number	D153
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited a product performance issue.The patient underwent a surgical intervention to remove this icd and implant a new product.No additional adverse patient effects were reported.Additional information was received that this icd recorded high out of range shock impedance measurements.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information was requested.This investigation will be updated should further information be provided.

• Brand Name: DYNAGEN? EL ICD DR
• Common Device Name: Implantable Cardioverter Defibrillator (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 ; +1(651)582-6168
• MDR Report Key: 50024788
• Report Number: 2124215-2026-39970
• Device Sequence Number: 9752437
• Product Code: LWS
• UDI-Device Identifier: 00802526534829
• UDI-Public: (01)00802526534829(17)241005
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/24/2026

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: 10/05/2024
• Device Model Number: D153
• Device Catalogue Number: D153
• Device Lot Number: 237554
• 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: 07/02/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2022
• 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; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male