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

Model Number	D150
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) didn't provide successful shocks for the patient's ventricular tachycardia (vt).Technical services (ts) reviewed device data and confirmed there were no reverse polarity shocks and no therapy exhaustion.Ts also confirmed there were inconsistent and unsuccessful shocks.At the beginning of the vt episode, a shock was provided that slowed the rhythm below the rate cut off.The rhythm went back to vt, and three shocks were provided that were unsuccessful.The fourth shock accelerated the arrhythmia to ventricular fibrillation (vf).The fifth shock converted the rhythm.The rhythm went back to vt, and a shock was provided which accelerated the arrythmia to vf again.The second shock was unsuccessful, and the third shock converted the arrhythmia.Ts recommended performing a defibrillation threshold (dft) test and adjusting therapy zones as a non-invasive option.A dft was performed and was successful.The plan was to implant a superior vena cava (svc) coil.A dual coil right ventricular (rv) lead was implanted.This icd remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: DYNAGEN? EL ICD VR
• 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: 50069853
• Report Number: 2124215-2026-40577
• Device Sequence Number: 18762191
• Product Code: LWS
• UDI-Device Identifier: 00802526534287
• UDI-Public: (01)00802526534287(17)201008
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2026

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: 10/08/2020
• Device Model Number: D150
• Device Catalogue Number: D150
• Device Lot Number: 244099
• 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: 07/14/2026
• Supplement Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 08/11/2026
• Date Device Manufactured: 10/25/2018
• 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; Life Threatening
• Patient Age: 75 YR
• Patient Sex: Male