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

Model Number 2088TC/46

Device Problem Difficult to Insert (1316)

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

Event Date 09/30/2022

Event Type  malfunction  

Event Description

Related manufacturer reference number: 2017865-2022-42335.Related manufacturer reference number: 2017865-2022-42337.It was reported that the patient presented for lead revision procedure due to lead fracture sustained by their right ventricular lead.During the procedure, the new right ventricular lead failed to connect to the pacemaker header due to a loose fitting set screw that could not tighten the lead in place.The pacemaker was explanted and replaced and the procedure was completed using an alternate atrial lead on (b)(6) 2022.The patient was stable.

Manufacturer Narrative

B5 - "atrial" should not have been mentioned as the lead replacement was for the right ventricular lead.

Event Description

It was reported that the patient presented for lead revision procedure due to lead fracture sustained by their right ventricular lead.During the procedure, the new right ventricular lead failed to connect to the pacemaker header due to a loose fitting set screw that could not tighten the lead in place.The pacemaker was explanted and replaced and the procedure was completed using an alternate lead on (b)(6) 2022.The patient was stable.

• Brand Name: TENDRIL STS
• 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: 15635400
• MDR Text Key: 306332849
• Report Number: 2017865-2022-42336
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502870
• UDI-Public: 05414734502870
• 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,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2088TC/46
• Device Catalogue Number: 2088TC-46
• Device Lot Number: P000151923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2022
• 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
• Patient Age: 43 YR
• Patient Sex: Female