MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL STS; NO MATCH

Model Number 2088TC/58

Device Problems Difficult to Fold, Unfold or Collapse (1254); High impedance (1291); Difficult to Advance (2920)

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

Event Date 09/28/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented to the hospital for a scheduled implant procedure.During procedure, the right ventricular (rv) lead was found difficult to have a stylet inserted displaying resistance and multiple attempts of rv lead re-positioning were performed due to high pacing impedance resulting in difficulty extending helix.The rv lead was removed and replaced on (b)(6) 2023.The patient had no adverse consequences.

Manufacturer Narrative

The reported events were high pacing lead impedance, stylet difficult to advance, and helix mechanism issue.A complete lead, without a stylet with helix retracted and clogged with dried blood, was returned in one piece for analysis.The reported event of stylet difficulty to advance and helix mechanism issue was confirmed.An x-ray examination found the inner coil being over-torqued at the connector region with damaged inner coil consistent with procedural damage.After cutting the lead, cleaning the distal portion of the lead, and applying torque directly to the inner coil, the helix could be extended/retracted, and helix extension length met specification.The cause of helix mechanism issue was isolated to dried blood in the helix region and over-torqued of the inner coil.The reported event of high pacing lead impedance was not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual inspection did not find any anomalies on the lead body.

• Brand Name: TENDRIL STS
• Type of Device: NO MATCH
• 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: 17962229
• MDR Text Key: 326386780
• Report Number: 2017865-2023-49720
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502894
• UDI-Public: 05414734502894
• Combination Product (y/n): Y
• Reporter Country Code: CO
• PMA/PMN Number: P960013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2088TC/58
• Device Lot Number: P000168782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2023
• 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