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

Model Number 2088TC/46

Device Problems Difficult to Fold, Unfold or Collapse (1254); High impedance (1291); Loose or Intermittent Connection (1371); Capturing Problem (2891)

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

Event Date 07/19/2021

Event Type  malfunction  

Event Description

It was reported a patient presented for a procedure on (b)(6) 2021.During placement of the atrial lead, an x-ray showed there was a helix anomaly which caused increased pacing impedance.High capture thresholds were also noted and the atrial lead was replaced.When the physician checked the connection with the new atrial lead, the suture sleeves were loose.This was corrected and normal parameters were obtained.Post-procedure there were no patient consequences.

Manufacturer Narrative

The damage found was sustained during procedure.The lead was otherwise normal.

• 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
• MDR Report Key: 12213071
• MDR Text Key: 263091589
• Report Number: 2017865-2021-26569
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502870
• UDI-Public: 05414734502870
• Combination Product (y/n): Y
• PMA/PMN Number: P960013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 2088TC/46
• Device Catalogue Number: 2088TC-46
• Device Lot Number: P000112662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1