MAUDE Adverse Event Report: ABBOTT QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/86

Device Problems Failure to Capture (1081); Device Dislodged or Dislocated (2923)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 07/29/2020

Event Type  Injury  

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 a follow-up in clinic, an increase in capture threshold resulting in a loss of capture and phrenic nerve stimulation was noted on the left ventricular (lv) lead.X-ray imaging was performed and confirmed lv lead dislodgement.The lv lead was explanted and replaced.The patient was stable.

Manufacturer Narrative

As received, a complete lead was returned in one piece for analysis.Electrical testing did not find any indication of conductor fractures or internal shorts.X-ray and visual inspection of the lead found no anomalies.The reported events of loss of capture, dislodgement, and phrenic nerve stimulation were not confirmed.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10393292
• MDR Text Key: 202502727
• Report Number: 2017865-2020-11328
• 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: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: S000063258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/11/2020
• Supplement Dates Manufacturer Received: 09/09/2020
• Supplement Dates FDA Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention