MAUDE Adverse Event Report: ABBOTT QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/86

Device Problems Break (1069); Difficult to Remove (1528); Failure to Disconnect (2541); Material Twisted/Bent (2981)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2020

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

During initial implant, after removing the delivery introducer, the stylet of the left ventricular (lv) lead was noted to be bent at the suture sleeve.The physician attempted to straighten the stylet with no success.The lv lead was explanted and replaced.The patient was stable.The patient was stable.

Manufacturer Narrative

As received, a complete lead was returned in one piece with the stylet stuck inside the lead.The cause of the reported event of break on the distal pin of the connector was confirmed and isolated to procedural damage.The reported event of failure to remove stylet from the lead was confirmed and isolated to the bunching of stripped stylet, polytetrafluoroethylene coating and inner coil.A review of the device history record confirmed that no issues were identified related to this reported event.Abbott is continuing to monitor this issue.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11052147
• MDR Text Key: 223140084
• Report Number: 2017865-2020-23312
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: S000078586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 03/30/2021
• Supplement Dates FDA Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1