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

Model Number	D023
Medical Device Problem Codes	Battery Problem (2885); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) reached elective replacement indicator state resulting to device data upload anomaly.The boston scientific technical services (ts) consultant discussed that the device battery could go to end of life battery state at any time and device replacement was recommended.Subsequently, tachy therapy was programmed off.The ts consultant discussed that if the pacing mode is currently deactivated, this therapy cannot be reactivated after the battery capacity is depleted, though this may be turned off later if this remains in a sensing-only mode.As of this time, this icd remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) reached elective replacement indicator state resulting to device data upload anomaly.The boston scientific technical services (ts) consultant discussed that the device battery could go to end of life battery state at any time and device replacement was recommended.Subsequently, tachy therapy was programmed off.The ts consultant discussed that if the pacing mode is currently deactivated, this therapy cannot be reactivated after the battery capacity is depleted, though this may be turned off later if this remains in a sensing-only mode.As of this time, this icd remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of gas gauge/longevity not as expected was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected on the lack of objective evidence of a device defect/malfunction and passing product record reviews.

• Brand Name: DYNAGEN MINI 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: 24968282
• Report Number: 2124215-2026-22052
• Device Sequence Number: 10496248
• Product Code: LWS
• UDI-Device Identifier: 00802526533921
• UDI-Public: (01)00802526533921(17)220810
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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: 08/10/2022
• Device Model Number: D023
• Device Catalogue Number: D023
• Device Lot Number: 253881
• 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: 04/15/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 06/17/2026
• Date Device Manufactured: 09/18/2020
• 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
• Patient Age: 84 YR
• Patient Sex: Male