MAUDE Adverse Event Report: ABBOTT QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/86

Device Problems Difficult to Insert (1316); Use of Device Problem (1670); Low impedance (2285)

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

Event Date 04/16/2021

Event Type  malfunction  

Event Description

During the initial implant procedure, low pacing impedance was noted on the left ventricular (lv) lead.The physician also noted the abnormal curvature of the patient¿s anatomy made placement of the lead difficult.The lv lead was explanted and a new lead was implanted to resolve the event.The patient was stable.

Event Description

Additional information was received that the left ventricular (lv) lead had difficulty advancing with the guidewire.

Manufacturer Narrative

The reported events were low pacing impedance and guidewire insertion difficulty.As received, a complete lead without the guidewire was returned in one piece for analysis.The reported event of low pacing impedance was not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.The reported event of guidewire insertion difficulty was confirmed.X-ray inspection of the lead found the damaged coil at the s-curve region.The cause of the reported event guidewire insertion difficulty was isolated to the damaged coil found on the lead consistent with procedural damage.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11752078
• MDR Text Key: 248159642
• Report Number: 2017865-2021-16931
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• 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: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: S000080265
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/30/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1