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

Model Number	D152
Medical Device Problem Codes	Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Discomfort (2330); Shock from Patient Lead(s) (3162)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) delivered one burst of anti-tachycardia pacing (atp) and seven shocks as inappropriate therapy for atrial fibrillation (af) with rapid ventricular response (rvr).Technical services (ts) was consulted and discussed stored as well as programming options based on the patients rhythm.Additionally, the patient reported that the device felt warm and hot intermittently.Ts performed an analysis of device battery and it was determined the battery was depleting normally, with power consumption stable.The device function is normal since high power events would be reflected in power consumption or monitoring voltage, with both normal and no device issues noted.This device remains in service.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN? EL ICD DR
• Common Device Name: Implantable Cardioverter Defibrillator (Non-Crt)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel E91 T 862; EI E91 T862
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 50416011
• Report Number: 2124215-2026-45358
• Device Sequence Number: 10213670
• Product Code: LWS
• UDI-Device Identifier: 00802526534324
• UDI-Public: (01)00802526534324(17)181020
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2026

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: 10/20/2018
• Device Model Number: D152
• Device Catalogue Number: D152
• Device Lot Number: 521797
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 11/01/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Male