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

Model Number	D020
Medical Device Problem Codes	High impedance (1291); Over-Sensing (1438); Delayed Charge Time (2586); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) longevity decreased from eight months last month to elective replacement indicator (eri).Technical services (ts) was consulted, noted two out of range shock impedance alerts that were greater than 125, a signal artifact monitor (sam) disable episode was found that appeared to be procedure or electromagnetic interference (emi) related.Ts provided an analysis of device data, the icd was found to be depleting normally and the eri was declared due to two charge times exceeding fifteen seconds, ts noted that a normal eri to end of life (eol) timing is applicable.Ts suggested considering raising the shock impedance limit.This icd remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing and sensing functions were tested.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) longevity decreased from eight months last month to elective replacement indicator (eri).Technical services (ts) was consulted, noted two out of range shock impedance alerts that were greater than 125, a signal artifact monitor (sam) disable episode was found that appeared to be procedure or electromagnetic interference (emi) related.Ts provided an analysis of device data, the icd was found to be depleting normally and the eri was declared due to two charge times exceeding fifteen seconds, ts noted that a normal eri to end of life (eol) timing is applicable.Ts suggested considering raising the shock impedance limit.This icd remains in service.No adverse patient effects were reported.Device explanted due to normal battery depletion (nbd) and returned.

• Brand Name: DYNAGEN? MINI 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 ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 22664022
• Report Number: 2124215-2025-52031
• Device Sequence Number: 11682004
• Product Code: LWS
• UDI-Device Identifier: 00802526533860
• UDI-Public: (01)00802526533860(17)190712
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 12/19/2025

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: 07/12/2019
• Device Model Number: D020
• Device Catalogue Number: D020
• Device Lot Number: 214433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2017
• 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: 64 YR
• Patient Sex: Female