MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) RIATA ST OPTIM LEAD; DEFIBRILLATION LEAD

Model Number 7020/60

Device Problems Fracture (1260); High impedance (1291); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Capturing Problem (2891); Device Sensing Problem (2917)

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

Event Date 11/26/2021

Event Type  Injury  

Event Description

It was reported that a patient presented in the emergency room due to right ventricular (rv) lead with oversensing noise, r-wave amplitude variation, high pacing impedance, and high capture threshold resulting in inappropriate therapy delivered.No changes or intervention was performed.The patient condition was stable.

Event Description

New information received notes that the right ventricular (rv) lead had a fracture.The patient condition is stable.

Event Description

New information received notes that the rv lead was explanted.The patient condition was stable.

Event Description

New information received notes that the rv lead was capped on 3 mar 2022.The patient condition was stable.

Manufacturer Narrative

Correction: d6b - this report is to retract the date of explant date given new information that the right ventricular lead was capped and not explanted on (b)(6) 2022.

• Brand Name: RIATA ST OPTIM LEAD
• Type of Device: DEFIBRILLATION LEAD
• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13026274
• MDR Text Key: 282400441
• Report Number: 2017865-2021-39515
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2010
• Device Model Number: 7020/60
• Device Lot Number: 0002247047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2007
• 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: FORTIFY VR ICD
• Patient Outcome(s): Life Threatening
• Patient Age: 47 YR
• Patient Sex: Female