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

Model Number	D412
Medical Device Problem Codes	Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.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 electrogram (egm) review was requested for this implantable cardioverter defibrillator (icd) system due to reported shock.Upon review, inappropriate anti-tachycardia pacing (atp) was delivered for supraventricular tachycardia (svt).Afterwards, a shock was delivered and converted the rhythm.Technical services (ts) discussed troubleshooting options and programming considerations.This icd remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding product return status.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 electrogram (egm) review was requested for this implantable cardioverter defibrillator (icd) system due to reported shock.Upon review, inappropriate anti-tachycardia pacing (atp) was delivered for supraventricular tachycardia (svt).Afterwards, a shock was delivered and converted the rhythm.Technical services (ts) discussed troubleshooting options and programming considerations.This icd remains in service.No additional adverse patient effects were reported.Additional information received reported that this single chamber icd system was explanted and upgraded to a dual chamber icd system with a right atrial (ra) lead.No additional adverse patient effects were reported.Product return was requested.

• Brand Name: PERCIVA? 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 ; +1(651)582-6168
• MDR Report Key: 25418325
• Report Number: 2124215-2026-30336
• Device Sequence Number: 12283586
• Product Code: LWS
• UDI-Device Identifier: 00802526587924
• UDI-Public: (01)00802526587924(17)261127
• 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: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2026

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 Model Number: D412
• Device Catalogue Number: D412
• Device Lot Number: 240920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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: 05/22/2026; 08/10/2026
• Initial Report FDA Received Date: 06/06/2026
• Supplement Report FDA Received Date: 06/15/2026; 08/12/2026
• Date Device Manufactured: 12/11/2024
• 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: 77 YR
• Patient Sex: Male