MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN? EL ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

Model Number	D151
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device remains in service and was not returned for analysis; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) was explanted due to unknown reasons.This icd was successfully replaced, and no additional adverse patient effects were reported.This icd has not returned for analysis.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) was explanted due to unknown reasons.This icd was successfully replaced, and no additional adverse patient effects were reported.This icd has not returned for analysis.Additional information was received and it was reported that this icd was explanted due to therapy upgrade.No additional adverse patient effects were reported.This icd has not been returned for analysis.
Additional Manufacturer Narrative
This report is being submitted to update the information in section b5.This device remains in service and was not returned for analysis; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.

• Brand Name: DYNAGEN? EL ICD VR
• 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 ; 6515826168
• MDR Report Key: 25000174
• Report Number: 2124215-2026-22547
• Device Sequence Number: 18328255
• Product Code: LWS
• UDI-Device Identifier: 00802526534300
• UDI-Public: (01)00802526534300(17)200216
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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: 02/16/2020
• Device Model Number: D151
• Device Catalogue Number: D151
• Device Lot Number: 200390
• 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: 04/08/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 05/04/2026
• Date Device Manufactured: 03/06/2018
• 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: 58 YR
• Patient Sex: Female