MAUDE Adverse Event Report: ABBOTT QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/86

Device Problem Failure to Disconnect (2541)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/29/2019

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During initial implant procedure, after the left ventricular (lv) lead was implanted the stylet failed to extend.The lv lead was explanted and replaced.The patient was stable and will continue to be monitored.

Manufacturer Narrative

As received, a complete lead was returned in one piece with the stylet stuck inside the lead.Visual inspection of the lead found that the connector pin and crimp sleeve were pulled out of the connector assembly which is consistent with procedural damage.The cause of the reported event was isolated to the bunching of the stripped stylet, ptfe coating and inner coil.The reported event of failure to remove stylet from the lead was confirmed.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 9008308
• MDR Text Key: 157795378
• Report Number: 2017865-2019-13655
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 1458Q/86
• Device Lot Number: A000058044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1