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

Model Number	D150
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Read Input Signal (1581); Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited undersensing.It was noted the patient had a left ventricular assist device (lvad) and that appeared to be causing the undersensing.Ts reviewed the data and noted there was noise, but the noise was not oversensed.Additionally, ts noted the pump noise was larger in comparison to the r wave amplitude being small.Ts discussed this could happen due to deoxyribonucleic acid (dna).It was noted the patient followed up with an electrophysiologist (ep) and no changes were made to programming, as the ep did not feel programming changes were needed at this time.No adverse patient effects were reported.This icd remains in service.
Additional Manufacturer Narrative
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
• 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: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50772882
• Report Number: 2124215-2026-49114
• Device Sequence Number: 10528972
• Product Code: LWS
• UDI-Device Identifier: 00802526534287
• UDI-Public: (01)00802526534287(17)190720
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: 07/20/2019
• Device Model Number: D150
• Device Catalogue Number: D150
• Device Lot Number: 224938
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 08/10/2017
• 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: 65 YR
• Patient Sex: Male