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 Failure to Deliver Shock/Stimulation (1133); Over-Sensing (1438); Pacing Problem (1439)

Patient Problem Arrhythmia (1721)

Event Date 09/22/2023

Event Type  Injury  

Event Description

It was reported that upon review of transmission for the implantable cardioverter defibrillator (icd), inappropriate mode switching and ventricular tachycardia (vt) under the tachy cut off rate was observed.Programming changes were recommended and made.The patient was stable before, during and after the event.

Event Description

New information received notes the origin of the inappropriate mode switching was atrial oversensing.

• 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: 17909796
• MDR Text Key: 325336935
• Report Number: 2017865-2023-48299
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: CD2357-40Q
• Device Lot Number: A000085274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 10/13/2023
• Supplement Dates FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2019
• 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 TACHY MRI; TENDRIL STS
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male