MAUDE Adverse Event Report: ABBOTT QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/86

Device Problems Difficult to Insert (1316); Failure to Advance (2524)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

This product is registered as a combination product.The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

During an implant procedure, the stylet was unable to be inserted into the left ventricular (lv) lead.The lv lead was explanted and replaced to resolve the event and the patient was stable.

Manufacturer Narrative

The reported event of stylet failure to advance was confirmed.As received, a complete lead was returned in one piece.Visual inspection and x-ray examination found the inner coil kinked at the s-curve region.A stylet could not be fully inserted into the lead due to the inner coil being kinked at the s-curve region.The cause of stylet failure to advance was due to kinked coil which is consistent with procedural damage.Electrical testing did not find any indication of conductor fractures or internal shorts.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10870262
• MDR Text Key: 217302799
• Report Number: 2017865-2020-19005
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• 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: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: S000077958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1