MAUDE Adverse Event Report: ABBOTT QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/86

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

Patient Problem Syncope (1610)

Event Date 09/05/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient presented in clinic with synope.During interrogation a loss of pacing was noted on the device due to a loss of capture on the right ventricular (rv) and left ventricular (lv) lead.The device, rv lead, and lv lead were explanted and replaced.The patient was stable and will continue to be monitored.Related manufacturer report number: 2938836-2019-13897, related manufacturer report number: 2938836-2019-13896.

Manufacturer Narrative

As received, a complete lead was returned in one piece.Electrical testing did not find any indication of conductor fractures or internal shorts.The s-curve hump height was measured within specification.Visual examination found no anomalies.The reported events of loss of pacing and loss of capture were not confirmed.

• 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 ; 8184932577
• MDR Report Key: 9107084
• MDR Text Key: 159715793
• Report Number: 2017865-2019-14064
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 1458Q/86
• Device Lot Number: S000071253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2019
• 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
• Treatment: OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR; QUADRA ASSURA MP ICD
• Patient Outcome(s): Hospitalization; Required Intervention