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

Model Number	D401
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) experienced a ventricular tachycardia (vt) episode with a rate of 180 beats per minute on external telemetry, however, the device did not store the episode or provide treatment.The patient had to be externally shocked.Technical services (ts) was contacted and described the rate not being fast enough to store in the ventricular fibrillation (vf) zone and concluded normal device function.Additional information was received that this icd had been explanted and replaced due to an unknown reason.No additional adverse patient effects were reported, and this icd has not been returned for analysis.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.

• 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: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 23598576
• Report Number: 2124215-2025-84789
• Device Sequence Number: 10380203
• Product Code: LWS
• UDI-Device Identifier: 00802526587894
• UDI-Public: (01)00802526587894(17)261219
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 11/19/2025

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 Model Number: D401
• Device Catalogue Number: D401
• Device Lot Number: 257369
• 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: 10/23/2025
• Initial Report FDA Received Date: 11/19/2025
• Date Device Manufactured: 02/26/2025
• 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: 10 MO
• Patient Sex: Male