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

Model Number	D401
Medical Device Problem Codes	Signal Artifact/Noise (1036); Telemetry Discrepancy (1629); Interrogation Problem (4017)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) had exhibited a pocket infection and was successfully replaced with a non-boston scientific device.Additionally, difficulties to interrogate and noisy signals were noted no additional adverse patient effects were reported outside the revision procedure.This product has not been returned.
Additional Manufacturer Narrative
Follow up report 1 (device evaluation): the returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) had exhibited a pocket infection and was successfully replaced with a non-boston scientific device.Additionally, difficulties to interrogate and noisy signals were noted no additional adverse patient effects were reported outside the revision procedure.This product has not been returned.

• Brand Name: PERCIVA? ICD DR
• 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 ; 6515826168
• MDR Report Key: 22935439
• Report Number: 2124215-2025-61306
• Device Sequence Number: 9879066
• Product Code: LWS
• UDI-Device Identifier: 00802526587894
• UDI-Public: (01)00802526587894(17)210304
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 12/18/2025

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: 03/04/2021
• Device Model Number: D401
• Device Catalogue Number: D401
• Device Lot Number: 252670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2019
• 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: 85 YR
• Patient Sex: Male