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

Model Number	D153
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Shock from Patient Lead(s) (3162); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited oversensing of noisy signals, that resulted in inappropriate anti-tachycardia pacing (atp) and inappropriate shocks, electing the field representative to turn off tachycardia and bradycardia therapies.Technical services (ts) was notified of the plan to implant a competitors device and keep the icd implanted; however, therapy would remain off.The local field representative and ts discussed if the device could reset and turn therapy back on, in which ts stated there are rare cases of the device entering safety mode and becoming active again.No additional 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.If pertinent information is provided in the future, a supplemental report will be submitted.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited oversensing of noisy signals, that resulted in inappropriate anti-tachycardia pacing (atp) and inappropriate shocks, electing the field representative to turn off tachycardia and bradycardia therapies.Technical services (ts) was notified of the plan to implant a competitors device and keep the icd implanted; however, therapy would remain off.The local field representative and ts discussed if the device could reset and turn therapy back on, in which ts stated there are rare cases of the device entering safety mode and becoming active again.No additional adverse patient effects were reported.This icd remains in service.Additional information was received from the field that the only inappropriate anti-tachycardia pacing (atp) was delivered and no shocks due to oversensing of noisy signals.The local field representative noted the icd will remain in service, and no further adverse effects were reported.

• 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: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25636471
• Report Number: 2124215-2026-34158
• Device Sequence Number: 13117638
• Product Code: LWS
• UDI-Device Identifier: 00802526534829
• UDI-Public: (01)00802526534829(17)170128
• 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,Followup
• Report Date (Section B): 08/27/2026

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: 01/28/2017
• Device Model Number: D153
• Device Catalogue Number: D153
• Device Lot Number: 198186
• 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: 06/03/2026
• Supplement Date Received by Manufacturer: 07/02/2026; Not provided
• Initial Report FDA Received Date: 06/26/2026
• Supplement Report FDA Received Date: 07/06/2026; 09/04/2026
• Date Device Manufactured: 01/28/2015
• 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: Other
• Patient Age: 49 YR
• Patient Sex: Male