MAUDE Adverse Event Report: ABBOTT QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/86

Device Problems Product Quality Problem (1506); Fitting Problem (2183); No Pacing (3268)

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

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

This product is registered as a combination product.

Event Description

During the implant procedure, the df4/is4 connector could not properly fit onto the left ventricular (lv) lead.Other df4/is4 connectors were attempted to be used but also could not properly fit onto the lv lead, so a lead malfunction was suspected.The lv lead was explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

The complete lead was returned for analysis with reported events of a fitting problem during implant.Electrical tests did not find any shorts or discontinues on any of the conduction paths.The lead connector passed insertion testing into test icd device, but failed insertion test into the test is-4 connector sleeve.Dimensional analysis identified an over-sized diameter in a section of the connector boot that may have contributed to the sleeve insertion failure and reported field events.

Event Description

During the implant procedure, the df4/is4 connector could not properly fit onto the left ventricular (lv) lead which resulted in a loss of pacing.Other df4/is4 connectors were attempted to be used but also could not properly fit onto the lv lead, so a lead malfunction was suspected.The lv lead was explanted and replaced to resolve the event.The patient was in stable condition.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11314515
• MDR Text Key: 231391360
• Report Number: 2017865-2021-07920
• 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,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• 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: A000101159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1