MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCIVA? ICD DR; Implantable Cardioverter Defibrillator

Model Number	D413
Medical Device Problem Codes	High impedance (1291); Off-Label Use (1494)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains in service; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) recorded high impedance measurements in all channels dating prior to the explant date.Technical services (ts) was contacted and upon reviewing the data, noted that this icd was taken out of shipping mode days prior to implant which is consistent with high impedance measurements since there were no leads attached to the icd yet.After implanting, all measurements recorded were within normal limits.This icd remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) recorded high impedance measurements in all channels dating prior to the explant date.Technical services (ts) was contacted and upon reviewing the data, noted that this icd was taken out of shipping mode days prior to implant which is consistent with high impedance measurements since there were no leads attached to the icd yet.After implanting, all measurements recorded were within normal limits.This icd remains in service.No adverse patient effects were reported.Additional information received detailed that this icd was explanted due to infection.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• 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: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25368108
• Report Number: 2124215-2026-29517
• Device Sequence Number: 15946939
• Product Code: LWS
• UDI-Device Identifier: 00802526587955
• UDI-Public: (01)00802526587955(17)270710
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2026

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: D413
• Device Catalogue Number: D413
• Device Lot Number: 142561
• 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: 05/08/2026
• Supplement Date Received by Manufacturer: 06/18/2026; 09/23/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 06/29/2026; 09/25/2026
• Date Device Manufactured: 07/21/2025
• 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: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male