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

Model Number	D020
Medical Device Problem Codes	Premature Discharge of Battery (1057); Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) went to the emergency room (er) after receiving multiple shocks.The health care professional (hcp) interrogated the device and found no episodes stored.Technical services (ts) indicated the device was at end of life (eol), in this status the episodes are not stored.In addition, according to the hcp, the last interrogation showed that the device had approximately one year remaining of battery capacity.Therefore, premature battery depletion (pbd) was suspected, but it was not conclusive as the patient had received multiple shocks that could had depleted the battery capacity.As a result, this device was explanted and successfully replaced.No adverse patient effects were reported.At this time, this icd was already returned to boston scientific.
Additional Manufacturer Narrative
The returned icd was analyzed, passed all tests performed, and exhibited normal device characteristics.The reported event was not confirmed.Analysis found no evidence of device defect, malfunction, or damage outside the bounds of normal medical use.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) went to the emergency room (er) after receiving multiple shocks.The health care professional (hcp) interrogated the device and found no episodes stored.Technical services (ts) indicated the device was at end of life (eol), in this status the episodes are not stored.In addition, according to the hcp, the last interrogation showed that the device had approximately one year remaining of battery capacity.Therefore, premature battery depletion (pbd) was suspected, but it was not conclusive as the patient had received multiple shocks that could had depleted the battery capacity.As a result, this device was explanted and successfully replaced.No adverse patient effects were reported.At this time, this icd was already returned to boston scientific.

• 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: 22373738
• Report Number: 2124215-2025-43631
• Device Sequence Number: 20839513
• Product Code: LWS
• UDI-Device Identifier: 00802526533860
• UDI-Public: (01)00802526533860(17)190424
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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: 04/24/2019
• Device Model Number: D020
• Device Catalogue Number: D020
• Device Lot Number: 213664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Female