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); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the health care professional (hcp) called technical services (ts) and requested further review of this implantable cardioverter defibrillator (icd) stored inappropriate atrial tachy response (atr) episodes due to observed noisy signals on the right atrial (ra) and shock channels.Upon review of the episodes, ts confirmed the noisy signals on both the ra and shock channels.Ts noted that the noisy signals were oversensed and appeared to be electromagnetic interference (emi) in nature.Further review of the atr episodes showed the inhibition of atrial pacing, no asystole or inappropriate therapy was observed.Ts discussed possible causes of the emi with the hcp.At this time, the icd remains in service.No adverse patient effects were reported.

• 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: 20196718
• Report Number: 2124215-2024-56946
• Device Sequence Number: 6768996
• Product Code: LWS
• UDI-Device Identifier: 00802526587894
• UDI-Public: 00802526587894
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2024

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: 03/30/2025
• Device Model Number: D401
• Device Catalogue Number: D401
• Device Lot Number: 256205
• 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: 08/20/2024
• Initial Report FDA Received Date: 09/11/2024
• Date Device Manufactured: 04/13/2023
• 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: 83 YR
• Patient Sex: Male