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

Model Number	D400
Medical Device Problem Codes	Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) delivered six rounds of anti-tachycardia pacing (atp) and a shock for what appeared to be atrial fibrillation (af) with rapid ventricular response (rvr).During the delivery of the shock there was an alert for low shock impedance when attempting to deliver a shock.Then, the icd recorded two instances of code 1006 indicative of high voltage detected on shock lead during charge associated to the non-boston scientific right ventricular (rv) lead.Afterwards, the device was unable to provide further shocks.Technical services (ts) was consulted and after reviewing the data recommended possible troubleshooting options and device replacement.This icd remains in service.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) delivered six rounds of anti-tachycardia pacing (atp) and a shock for what appeared to be atrial fibrillation (af) with rapid ventricular response (rvr).During the delivery of the shock there was an alert for low shock impedance when attempting to deliver a shock.Then, the icd recorded two instances of code 1006 indicative of high voltage detected on shock lead during charge associated to the non-boston scientific right ventricular (rv) lead.Afterwards, the device was unable to provide further shocks.Technical services (ts) was consulted and after reviewing the data recommended possible troubleshooting options and device replacement.This icd remains in service.No additional adverse patient effects were reported.Additional information received stated that this icd was explanted, successfully replaced and has not been returned for analysis.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This report is being submitted to provide explant information.

• Brand Name: PERCIVA? ICD VR
• Common Device Name: implantable cardioverter defibrillator (ICD)
• 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: 23244713
• Report Number: 2124215-2025-71292
• Device Sequence Number: 18701363
• Product Code: LWS
• UDI-Device Identifier: 00802526587863
• UDI-Public: (01)00802526587863(17)250615
• 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: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2026

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: 06/15/2025
• Device Model Number: D400
• Device Catalogue Number: D400
• Device Lot Number: 115060
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/31/2025
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 10/17/2025; 07/30/2026
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 10/21/2025; 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• 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: 71 YR
• Patient Sex: Female