MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN EL ICD VR; Implantable Device

Model Number	D151
Medical Device Problem Codes	Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implantable cardioverter defibrillator (icd) exhibited a low voltage fault code.Boston scientific technical services (ts) confirmed the power consumption had been increasing in a gradual fashion, consistent with capacitor degradation due to hydrogen gas contained in the sealed pulse generator atmosphere, and referred the patient to clinic and suggested to disable the beeper.Additional information was received indicating a red call doctor (rcd) alert also appeared on the communicator.This device remains in service.No adverse patient effects were reported.

• Brand Name: DYNAGEN EL ICD VR
• Common Device Name: Implantable Device
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel E91 T 862; EI E91 T862
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 25741904
• Report Number: 2124215-2026-36469
• Device Sequence Number: 10459036
• Product Code: LWS
• UDI-Device Identifier: 00802526534300
• UDI-Public: (01)00802526534300(17)200410
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2026

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: 04/10/2020
• Device Model Number: D151
• Device Catalogue Number: D151
• Device Lot Number: 200847
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/13/2026
• 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: 06/09/2026
• Supplement Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 07/07/2026
• Supplement Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2018
• 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: 60 YR
• Patient Sex: Male