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

Model Number CD2357-40Q

Device Problems Over-Sensing (1438); Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574); Under-Sensing (1661); Device Sensing Problem (2917)

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

Event Date 02/20/2023

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2023-13550.It was reported that the patient presented to the clinic on (b)(6) 2023 for a follow-up.Review of the transmission revealed that there was ventricular under-sensing and drop in r-wave amplitude on the implantable cardioverter defibrillator (icd).There was post-sensed t-wave over-sensing on the icd.The device was reprogrammed.During programming changes it was discovered that capture threshold was elevated on the right ventricular lead.There were no adverse consequences to the patient.

Event Description

New information received notes the patient presented to the clinic on (b)(6) 2023 for a follow-up.Review of the transmission revealed that there was drop in r-wave amplitude on the implantable cardioverter defibrillator (icd).There was post-sensed t-wave over-sensing on the icd which caused inappropriate shock.During examination, it was discovered that capture threshold was elevated further on the right ventricular lead.The icd and the rv lead were reprogrammed.There were no adverse consequences to the patient.

• Brand Name: FORTIFY ASSURA DR ICD, US
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 16535068
• MDR Text Key: 311219253
• Report Number: 2017865-2023-13549
• 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: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: CD2357-40Q
• Device Catalogue Number: CD2357-40Q
• Device Lot Number: A000097792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2020
• 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: TENDRIL
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male