MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCIVA ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	D412
Medical Device Problem Codes	Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581)
Health Effect - Clinical Codes	Nausea (1970); Discomfort (2330); Shock from Patient Lead(s) (3162)
Date of Event	01/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve initial reporter contact details, but further information was unable to be obtained.
Event or Problem Description
It was reported that the patient implanted with this implantable cardioverter defibrillator (icd) system presented to the emergency room (er) after experiencing shocks/pulses while in the shower.Patient symptoms included discomfort and nausea.The patient was admitted to the hospital.A programmer was not available for interrogation, and a local field representative was paged for further assistance.Additional information received reported that the patient had received anti-tachycardia pacing (atp) and shocks, and the intrinsic amplitude had changed from 25mv (at implant) to 1.5 mv.There was no activity on the shock channel, and noise was observed in stored events.It was recommended that the patient see the electrophysiologist and get x-rays to confirm lead position.This icd system remains in service.No additional adverse patient effects were reported.

• Brand Name: PERCIVA ICD VR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 24329414
• Report Number: 2124215-2026-08162
• Device Sequence Number: 13207053
• Product Code: LWS
• UDI-Device Identifier: 00802526587924
• UDI-Public: (01)00802526587924(17)271020
• Combination Product (Y/N): N
• Initial Reporter State: PR
• 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
• Report Date (Section B): 02/12/2026

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 Model Number: D412
• Device Catalogue Number: D412
• Device Lot Number: 243009
• 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: 01/19/2026
• Initial Report FDA Received Date: 02/12/2026
• Date Device Manufactured: 11/11/2025
• 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
• Patient Age: 57 YR
• Patient Sex: Male