MAUDE Adverse Event Report: ABBOTT QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/75

Device Problems Failure to Capture (1081); High impedance (1291)

Patient Problem Cardiac Perforation (2513)

Event Date 04/04/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that there was a cardiac perforation by the left ventricular (lv) lead which resulted in an increased capture threshold, a loss of capture, and an increased pacing lead impedance (pli).The patient¿s hemodynamic state deteriorated due to the perforation.The lead was explanted to resolve the event and the patient was stable following the procedure.

Event Description

Additional information received indicated that a cardiac perforation did not occur, and the patient's hemodynamic state deteriorated as a result of the loss of capture.

Manufacturer Narrative

Additional information: as received, a complaint lead was returned in one piece.Visual examination found the four filers of the inner coil were fractured which is consistent with suture tie down forces, and there were no other anomalies noted.X-ray analysis was performed, which did not find any other anomalies.The reported events of increased capture threshold, a loss of capture, and increased impedance were confirmed and isolated the damage from suture tie down forces.

• 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
• MDR Report Key: 9419466
• MDR Text Key: 169446906
• Report Number: 2017865-2019-17489
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503334
• UDI-Public: 05414734503334
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 02/18/2020

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: 01/31/2020
• Device Model Number: 1458Q/75
• Device Catalogue Number: 1458Q-75
• Device Lot Number: A000035378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 12/06/2019; 02/10/2020
• Supplement Dates FDA Received: 12/20/2019; 02/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention