MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN? EL ICD DR; Implantable cardioverter defibrillator (ICD)

Model Number	D153
Medical Device Problem Codes	High impedance (1291); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the health care professional (hcp) called technical services (ts) and requested assistance with programming this implantable cardioverter defibrillator (icd) into magnetic resonance imaging (mri) protection mode.Ts reviewed the device settings and confirmed that the icd was not approved of mri due to non-boston scientific leads.Ts also noted the non-boston scientific right atrial (ra) lead exhibited consistent high out of range pacing impedance measurements.Ts advised if mri scan is performed it would be considered to be off label.The hcp noted the consistent high out of range pacing impedance measurements is known by physician and an off label order was sent.Ts assisted with programming the mri protection mode on.Later on, the mri protection mode was programmed off and device was evaluated and found to be operating as expected.No adverse patient effects were reported.This icd and non-boston scientific ra lead remain in service.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.

• Brand Name: DYNAGEN? EL ICD DR
• Common Device Name: Implantable cardioverter defibrillator (ICD)
• 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: 25820985
• Report Number: 2124215-2026-37897
• Device Sequence Number: 21435457
• Product Code: LWS
• UDI-Device Identifier: 00802526534829
• UDI-Public: (01)00802526534829(17)180125
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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: 01/25/2018
• Device Model Number: D153
• Device Catalogue Number: D153
• Device Lot Number: 203418
• 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: 06/23/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 07/14/2026
• Supplement Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 02/02/2016
• 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