MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) RIATA ACTIVE FIXATION; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 1580/60

Device Problems Fracture (1260); Naturally Worn (2988)

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

Event Date 02/15/2024

Event Type  Injury  

Event Description

It was reported that a patient presented with fracture noted on the patient's right ventricular lead.The lead was explanted and replaced on (b)(6) 2024.The patient was stable throughout.

Event Description

New information received notes that externalized conductors were noted on the lead at the time of revision.No further adverse consequences were reported.

• Brand Name: RIATA ACTIVE FIXATION
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 18842921
• MDR Text Key: 336957914
• Report Number: 2017865-2024-34208
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

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: 12/31/2010
• Device Model Number: 1580/60
• Device Lot Number: 0002138461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0457-2012
• Patient Sequence Number: 1
• Treatment: GALLANT DR.; OPTISENSE.
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male