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

Model Number	D151
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implantable cardioverter-defibrillator (icd) may be turned off, which raised concerns from the patient advocate.The technical services (ts) consultant recommended coordinating with the clinic staff and inquired whether a healthcare professional (hcp) could be present during the device check.At this time, the icd remains active.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN EL ICD VR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 23658602
• Report Number: 2124215-2025-86912
• Device Sequence Number: 13252302
• Product Code: LWS
• UDI-Device Identifier: 00802526534300
• UDI-Public: (01)00802526534300(17)170211
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/26/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/11/2017
• Device Model Number: D151
• Device Catalogue Number: D151
• Device Lot Number: 189002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/26/2025
• Date Device Manufactured: 02/11/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male