MAUDE Adverse Event Report: ABBOTT QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/86

Device Problems Failure to Capture (1081); No Pacing (3268)

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

Event Date 11/14/2022

Event Type  malfunction  

Event Description

During an implant procedure, a loss of pacing was observed on the left ventricular (lv) lead.The lv lead was explanted and replaced to resolve the event.The patient was stable and will continue to be monitored.

Event Description

Corrected information was received that a loss of capture was observed on the left ventricular (lv) lead, not a loss of pacing.

Manufacturer Narrative

Corrected data: b5 and h6.

Manufacturer Narrative

The reported event of loss of capture was not confirmed.As received, a complete lead was returned in one piece for evaluation.Electrical testing did not reveal any indication of conductor fractures or internal shorts.The lead connector passed insertion testing into the test icd device and the is-4 connector sleeve.Dimensional analysis of the connector boot was measured within the product specifications.Visual and x-ray examinations of the lead did not reveal any anomalies.

• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15920615
• MDR Text Key: 305826866
• Report Number: 2017865-2022-47749
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• Reporter Country Code: PL
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2023

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 Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: S000087746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 12/16/2022; 01/18/2023
• Supplement Dates FDA Received: 12/19/2022; 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2022
• 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