MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT? EL ICD VR; Implantable Cardioverter Defibrillator

Model Number	D232
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data was sent for engineering analysis.Analysis showed that the battery voltage is dropping rapidly and unpredictably triggering the low voltage anomaly.Device replacement was suggested.To date, this device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data was sent for engineering analysis.Analysis showed that the battery voltage is dropping rapidly and unpredictably triggering the low voltage anomaly.Device replacement was suggested.To date, this device remains in service.No adverse patient effects were reported.Additional information received indicates that the device was explanted and a new device was successfully placed.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This supplemental report was created to capture additional information in b5 event description and h6 impact codes.

• Brand Name: VIGILANT? EL 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 E91 T 862; EI E91 T862
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50750786
• Report Number: 2124215-2026-48862
• Device Sequence Number: 12977163
• Product Code: LWS
• UDI-Device Identifier: 00802526587788
• UDI-Public: (01)00802526587788(17)230223
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2026

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: 02/23/2023
• Device Model Number: D232
• Device Catalogue Number: D232
• Device Lot Number: 281187
• 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: 09/02/2026
• Supplement Date Received by Manufacturer: 09/11/2026; 09/22/2026
• Initial Report FDA Received Date: 09/14/2026
• Supplement Report FDA Received Date: 09/17/2026; 09/23/2026
• Date Device Manufactured: 03/19/2021
• 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: 65 YR
• Patient Sex: Male