MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCIVA? ICD DR; IMPLANTABLE DEVICE

Model Number	D401
Medical Device Problem Codes	Failure to Convert Rhythm (1540); Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The local area sales representative was contacted for additional information.Atthis 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) presented to the emergency room (er) after being shocked.The health care professional (hcp) called technical services (ts) and requested a consult review of the presenting electrogram (egm).Upon review, the presenting egm showed patient was in a ventricular arrhythmia.The device delivered a burst of anti-tachycardia pacing (atp) and shock in attempt to convert rhythm.The therapy was unable to convert the rhythm.Ts also noted there to be undersensing on the right ventricular (rv) lead channel.Ts provided programming optimization and recommended for further evaluation be performed by cardiology.At this time, no additional adverse patient effects were reported.This icd remains in service.

• Brand Name: PERCIVA? ICD DR
• 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 ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 25180123
• Report Number: 2124215-2026-26338
• Device Sequence Number: 10740782
• Product Code: LWS
• UDI-Device Identifier: 00802526587894
• UDI-Public: (01)00802526587894(17)260403
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2026

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: 04/03/2026
• Device Model Number: D401
• Device Catalogue Number: D401
• Device Lot Number: 256981
• 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: 04/21/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 06/29/2026
• Date Device Manufactured: 04/17/2024
• 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: 65 YR
• Patient Sex: Female