MAUDE Adverse Event Report: ABBOTT TENDRIL STS; PERMANENT PACEMAKER ELECTRODE

Model Number 2088TC/52

Device Problems Difficult to Insert (1316); Use of Device Problem (1670); Connection Problem (2900)

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

Event Date 09/03/2021

Event Type  malfunction  

Event Description

During implantation, the physician had difficulty inserting the stylet through the right atrial (ra) lead.The physician was then unable to implant the ra lead.The ra lead was explanted and replaced to resolved the event.The patient was stable.

Manufacturer Narrative

The reported events were unable to implant and difficulty to introduce the stylet kit into the lead.As received, a complete lead with a stylet was returned in one piece for analysis.The reported event of difficulty to introduce the stylet kit into the lead was not confirmed.X-ray of the lead showed no anomalies noted at the received stylet location.The returning stylet was able to be removed from the lead without any restriction, and no anomalies were noted on the returning stylet.The stylet insertion test was performed.The test stylet was able to be fully advanced thru the lead without any restriction.

• Brand Name: TENDRIL STS
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 12533121
• MDR Text Key: 273346751
• Report Number: 2017865-2021-30723
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502887
• UDI-Public: 05414734502887
• 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: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 2088TC/52
• Device Catalogue Number: 2088TC-52
• Device Lot Number: P000105425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1