MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCIVA? ICD DR; implantable cardioverter defibrillator

Model Number	D413
Medical Device Problem Code	Failure to Convert Rhythm (1540)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding event cause/resolution and initial reporter contact details.At this time, no further information is available.Should additional information become available this report will be updated.This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) system stored two ventricular episodes were appropriate tachy therapy was delivered and therapy was exhausted due to true ventricular tachycardia (vt).Therapy interrupted the rhythm, however the arrhythmia was incessant and continuous.Programming optimization was advised.This icd remains in service.No additional adverse patient effects were reported.

• Brand Name: PERCIVA? 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 ; +1(651)582-6168
• MDR Report Key: 25465733
• Report Number: 2124215-2026-31173
• Device Sequence Number: 13313191
• Product Code: LWS
• UDI-Device Identifier: 00802526587955
• UDI-Public: (01)00802526587955(17)231022
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2026

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: 10/22/2023
• Device Model Number: D413
• Device Catalogue Number: D413
• Device Lot Number: 129443
• Was Device Available for Evaluation?: No
• 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: 05/14/2026
• Supplement Date Received by Manufacturer: 07/06/2026; 08/06/2026
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 07/29/2026; 08/11/2026
• Date Device Manufactured: 11/01/2021
• 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: Life Threatening; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female