MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY ASSURA DR ICD, US; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number CD2357-40Q

Device Problems Signal Artifact/Noise (1036); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2023

Event Type  malfunction  

Event Description

It was reported that a patient presented remotely via (b)(4).Review of the transmission revealed noise on the implantable cardioverter defibrillator (icd).No changes or intervention was reported; the device will continue to be monitored.The patient condition was stable.

Manufacturer Narrative

Correction: please retract this report 2017865-2023-23618, the event is a complaint on the right ventricular lead and not the implantable cardioverter defibrillator.

• Brand Name: FORTIFY ASSURA DR ICD, US
• Type of Device: 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: 17162175
• MDR Text Key: 317471886
• Report Number: 2017865-2023-23618
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734508094
• UDI-Public: 05414734508094
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/11/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: CD2357-40Q
• Device Catalogue Number: CD2357-40Q
• Device Lot Number: A000056558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/20/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DURATA RV LEAD.; ISOFLEX OPTIM RA LEAD.
• Patient Age: 61 YR
• Patient Sex: Male