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

Model Number 2088TC/52

Device Problems Difficult to Fold, Unfold or Collapse (1254); Difficult to Insert (1316); Capturing Problem (2891); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923)

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

Event Date 06/22/2021

Event Type  Injury  

Event Description

It was noted that there was an increased capture threshold on the right atrial (ra) lead.An x-ray was performed and revealed a dislodgement.During the revision procedure for the ra lead to resolve the dislodgement, r wave amp variation was observed and it was noted that the stylet was difficult to insert and the helix was unable to be extended.The ra lead was explanted and replaced to resolve the event.The patient was stable.

Manufacturer Narrative

The reported events were lead dislodgement, inadequate capture, device sensing problem, difficult to insert the stylet, and a helix mechanism issue.As received, a complete lead was returned in one piece.The reported events for a helix mechanism issue and the difficulty of inserting the stylet were confirmed.Visual inspection of the lead found the retracted helix clogged with blood.X-ray examination found an over torqued inner coil at the connector region.The measured full helix extension length was within product specification.The reported events for inadequate capture and device sensing problem were not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.The cause of the reported event for a helix mechanism issue was due to the helix being clogged with blood and an over torqued inner coil at the connector region.The cause of the reported event for the difficulty of inserting the stylet was due to an over torqued inner coil at the connector region.

• Brand Name: TENDRIL STS
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 12129888
• MDR Text Key: 260312190
• Report Number: 2017865-2021-25141
• 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: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 2088TC/52
• Device Catalogue Number: 2088TC-52
• Device Lot Number: P000113875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention