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

Model Number	D153
Medical Device Problem Codes	Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	06/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) delivered inappropriate anti-tachycardia pacing (atp) and shocks for atrial fibrillation (af) with rapid ventricular response (rvr).The last shock was delivered with reversed polarity and analysis from technical services (ts) noted when the device is interrogated, there will be a code 1005.Engineering guidance discussed to clear the fault and evaluate the integrity of the device and lead system.It was recommended to consider lead replacement.No additional adverse patient effects were reported.This icd remains in service.

• 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: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25738395
• Report Number: 2124215-2026-36335
• Device Sequence Number: 10554168
• Product Code: LWS
• UDI-Device Identifier: 00802526534829
• UDI-Public: (01)00802526534829(17)210107
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: 01/07/2021
• Device Model Number: D153
• Device Catalogue Number: D153
• Device Lot Number: 215563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 07/07/2026
• Supplement Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 01/21/2019
• 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: Other
• Patient Age: 72 YR
• Patient Sex: Male