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); Inappropriate or Unexpected Reset (2959); No Apparent Adverse Event (3189)

Patient Problems Arrhythmia (1721); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2023

Event Type  Injury  

Manufacturer Narrative

Further information was requested but not received.

Event Description

It was reported that the patient presented in clinic due to an arrhythmia.Device interrogation revealed unexpected reset and no high voltage output the implantable cardioverter defibrillator (icd).The physician elected to externally defibrillated the patient to get back to sinus.The patient was in stable condition.

Manufacturer Narrative

Correction: please retract this report 2017865-2024-00442, the same issue was previously reported as 2017865-2024-00141.¿.

• 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: 18451135
• MDR Text Key: 332177023
• Report Number: 2017865-2024-00442
• 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: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2024

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: 06/30/2023
• Device Model Number: CD2357-40Q
• Device Lot Number: A000111425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 01/26/2024; 02/15/2024
• Supplement Dates FDA Received: 01/26/2024; 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Female