MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ELLIPSE VR ICD; Pulse generator, permanent, implantable

Model Number	CD1311-36Q
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented in clinic for a follow up.Device interrogation revealed noise on the implantable cardioverter defibrillator (icd).Programming changes were performed to resolve the issue.There were no patient consequences.

• Brand Name: ELLIPSE VR ICD
• Common Device Name: Pulse generator, permanent, implantable
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 19716724
• Report Number: 2017865-2024-59926
• Device Sequence Number: 8206440
• Product Code: NVZ
• UDI-Device Identifier: 05414734506113
• UDI-Public: (01)05414734506113(10)S000014800(17)170630
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2024

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: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: CD1311-36Q
• Device Lot Number: S000014800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2015
• 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 Sex: Unknown