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

Model Number CD2357-40Q

Device Problem Delayed Charge Time (2586)

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

Event Date 10/26/2022

Event Type  Injury  

Event Description

It was reported that a patient presented to the clinic on (b)(6) 2022 for a implantable cardioverter defibrillator (icd) implant procedure.After implant and closure of the patient pocket, it was noted that the device was experiencing long charge times.The pocket was reopened and the icd was explanted and replaced.The patient was stable throughout.

Manufacturer Narrative

The reported event of long charge time could not be confirmed.Review of device data showed no long charge time had occurred.Telemetry, impedance, sensing, pacing, high voltage (hv) output, and capacitor maintenance functions of the device were tested and found to be normal.

• 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: 15744365
• MDR Text Key: 303165657
• Report Number: 2017865-2022-44500
• 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: 12/05/2022

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 Model Number: CD2357-40Q
• Device Catalogue Number: CD2357-40Q
• Device Lot Number: A000131349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/07/2022
• Supplement Dates Manufacturer Received: 12/02/2022
• Supplement Dates FDA Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2022
• 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 RIGHT VENTRICULAR LEAD; TENDRIL RIGHT ATRIAL LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Race: Black Or African American