MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) BI,TINED,IS-1, J ,ENDO LEAD; permanent pacemaker Electrode

Model Number 1222T/52

Device Problem Insufficient Information (3190)

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

Event Date 03/21/2024

Event Type  Injury  

Event Description

It was reported during in clinic follow up that the atrial lead exhibited oversensing noise.The lead was explanted along with another atrial lead that was capped on (b)(6) 2000 for an unknown reason.The patient was stable and asymptomatic.

• Brand Name: BI,TINED,IS-1, J ,ENDO LEAD
• Type of Device: permanent pacemaker Electrode
• 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: 19056227
• MDR Text Key: 339549844
• Report Number: 2017865-2024-37852
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1222T/52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• 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: ASSURITY
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 83 KG