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

Model Number 2088TC/58

Device Problems Difficult to Fold, Unfold or Collapse (1254); Difficult to Insert (1316)

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

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

This product is registered as a combination product.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer reference number: 2017865-2021-09401, related manufacturer reference number: 2017865-2021-09404.It was reported that patient presented for a routine lead implant procedure.During the procedure, the pacemaker lead exhibited stylet insertion difficulty and failure to extend the helix.After failure to fixate the first lead, the physician attempted lead placement two more times with two different leads.All three leads exhibited the same anomalies.The physician was able to eventually implant a new lead successfully.The patient was in stable condition.

Manufacturer Narrative

The reported event of difficult stylet insertion and helix mechanism issue were confirmed.Final analysis found the lead was returned with the helix clogged with blood and the inner coil was over-torqued.After cleaning, the helix extended and retracted normally within specification.A stylet insertion test could not be performed due to the over-torqued inner coil consistent with procedural damage.The lead was otherwise normal; no anomalies were found.

• 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: 11395813
• MDR Text Key: 234208323
• Report Number: 2017865-2021-09403
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502894
• UDI-Public: 05414734502894
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 2088TC/58
• Device Catalogue Number: 2088TC-58
• Device Lot Number: A000102104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TENDRIL STS; TENDRIL STS
• Patient Age: 83 YR