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

Model Number	D153
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Pacing Problem (1439)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this right ventricular (rv) lead with the implantable cardioverter defibrillator (icd) exhibited noise and pacing inhibition up to 2 seconds.The noise also led to inappropriate anti-tachycardia pacing (atp) being delivered.The lead pace impedance was also noted to be high out of range.Technical services (ts) recommended potential programming changes for this lead.Lead replacement was recommended.This icd and rv lead remain in service.No adverse patient effects were reported.

• Brand Name: DYNAGEN? EL ICD DR
• 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: 25400916
• Report Number: 2124215-2026-29994
• Device Sequence Number: 17664128
• Product Code: LWS
• UDI-Device Identifier: 00802526534829
• UDI-Public: (01)00802526534829(17)180811
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2026

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: Lay User/Patient
• Device Expiration Date: 08/11/2018
• Device Model Number: D153
• Device Catalogue Number: D153
• Device Lot Number: 205580
• 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: 05/06/2026
• Supplement Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 06/04/2026
• Supplement Report FDA Received Date: 07/02/2026
• Date Device Manufactured: 01/25/2017
• 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: 74 YR
• Patient Sex: Male