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

Model Number	D400
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) inappropriately stored arrhythmia episodes as a result of oversensing electrocautery noise due to a surgical procedure.Boston scientific technical services (ts) also observed the internal clock of the device could be off accounting for the time discrepancy of episodes.No adverse patient effects were reported.At this time, this device remains in service.

• Brand Name: PERCIVA ICD VR
• 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: 18852372
• Report Number: 2124215-2024-13904
• Device Sequence Number: 15307406
• Product Code: LWS
• UDI-Device Identifier: 00802526587863
• UDI-Public: 00802526587863
• 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: 2022
• 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): 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/25/2023
• Device Model Number: D400
• Device Catalogue Number: D400
• Device Lot Number: 112801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2021
• 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
• Patient Age: 65 YR
• Patient Sex: Male