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

Model Number	D401
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930)
Date of Event	07/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) was part of a system revision due to suspected infection and allergic reaction.Reportedly, the patient was for an atrial lead revision and when the pocket was opened, some sort of puss was noted.There were no additional adverse patient effects reported.This icd was explanted.
Additional Manufacturer Narrative
This supplemental report was created to update initial reporter.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) was part of a system revision due to suspected infection and allergic reaction.Reportedly, the patient was for an atrial lead revision and when the pocket was opened, some sort of puss was noted.There were no additional adverse patient effects reported.This icd was explanted.

• Brand Name: PERCIVA ICD DR
• 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: 22698248
• Report Number: 2124215-2025-53719
• Device Sequence Number: 13008385
• Product Code: LWS
• UDI-Device Identifier: 00802526587894
• UDI-Public: (01)00802526587894(17)230506
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/06/2023
• Device Model Number: D401
• Device Catalogue Number: D401
• Device Lot Number: 254471
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 04/03/2026
• Date Device Manufactured: 06/02/2021
• 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: 4 YR
• Patient Sex: Female