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

Model Number	D153
Medical Device Problem Codes	Over-Sensing (1438); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) recorded possible atrial fibrillation episodes for which the healthcare professional (hcp) requested assessment.The hcp also confirmed awareness of low p-wave amplitudes and having adjusted ventricular sensitivity.Technical discussion included the possibility of at/af episodes as well as intermittent far-field oversensing.The healthcare professional indicated that the condition had been ongoing for an extended period with continued monitoring and multiple sensitivity adjustments.Troubleshooting options related to p-wave sensing, sensitivity programming, and blanking parameters were discussed.The issue appeared to be chronic in nature.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.

• 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: 25452715
• Report Number: 2124215-2026-30900
• Device Sequence Number: 10409776
• Product Code: LWS
• UDI-Device Identifier: 00802526534829
• UDI-Public: (01)00802526534829(17)240114
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

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: 01/14/2024
• Device Model Number: D153
• Device Catalogue Number: D153
• Device Lot Number: 232189
• 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: 05/18/2026
• Initial Report FDA Received Date: 06/10/2026
• Date Device Manufactured: 01/21/2022
• 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 Sex: Male