MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL SDX LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 1688TC/52

Device Problems High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Capturing Problem (2891)

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

Event Date 03/15/2022

Event Type  Injury  

Event Description

It was reported that the patient presented for a device change-out procedure.Upon interrogation, prior to procedure, the right atrial (ra) lead exhibited high capture threshold, noise over-sensing resulting in inappropriate automatic mode switch episodes and high pacing impedance.The ra lead was capped and replaced on (b)(6) 2022.The patient was in stable condition.

• Brand Name: TENDRIL SDX 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13935134
• MDR Text Key: 288091247
• Report Number: 2017865-2022-06224
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734501859
• UDI-Public: 05414734501859
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P960013
• 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: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2013
• Device Model Number: 1688TC/52
• Device Catalogue Number: 1688TC-52
• Device Lot Number: 2932900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2010
• 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: LEFT VENTRICULAR LEAD; SPRINT QUATTRO SECURE; UNIFY ASSURA
• Patient Outcome(s): Required Intervention
• Patient Sex: Female