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

Model Number	D401
Medical Device Problem Codes	Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator device was explanted due to premature battery depletion and displaying fault code 1003.A new device was successfully implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.Visual examination identified no anomalies.A review of the device memory confirmed that several charge time exceeded faults were recorded, which resulted in the device triggering end of life (eol) battery status.Tachycardia therapy was not available as the device was unable to deliver energy within the allowed charge time limits.The device case was removed to facilitate inspection of the internal components and further testing; internal visual inspection noted no irregularities.The battery was removed from the device and replaced with an external power source.The current drain was measured and found to be normal.Detailed analysis of the battery identified an intermittent low resistance pathway, which resulted in the clinically observed fault code, and premature battery depletion.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator device was explanted due to premature battery depletion and displaying fault code 1003.A new device was successfully implanted.No additional adverse patient effects were reported.

• 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: 19998037
• Report Number: 2124215-2024-50997
• Device Sequence Number: 7258098
• Product Code: LWS
• UDI-Device Identifier: 00802526587894
• UDI-Public: 00802526587894
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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: 02/12/2020
• Device Model Number: D401
• Device Catalogue Number: D401
• Device Lot Number: 250879
• 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: 07/26/2024
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 08/16/2024
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2018
• 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: 69 YR
• Patient Sex: Female