MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OSCOR PACING LEAD

Model Number ZY52PJUSBV

Device Problems Over-Sensing (1438); Pacing Problem (1439); Low impedance (2285); Capturing Problem (2891); Device Sensing Problem (2917)

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

Event Date 06/27/2022

Event Type  Injury  

Event Description

It was reported that the patient presented for a routine generator change.Upon interrogation, prior to the procedure, it was noted that the atrial lead exhibited decreased atrial sensing, low pacing impedance, high capture threshold, and episodes of noise oversensing causing inappropriate mode switch.The atrial lead was capped and replaced (b)(6) 2022.The patient was in stable condition throughout the procedure.

• Brand Name: OSCOR PACING LEAD
• Type of Device: PACING 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: 15003217
• MDR Text Key: 295808779
• Report Number: 2017865-2022-14852
• Device Sequence Number: 1
• Product Code: DTD
• 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: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZY52PJUSBV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2022
• 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
• Treatment: ASSURITY; RIGHT VENTRICULAR LEAD
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 119 KG