MAUDE Adverse Event Report: ABBOTT QUARTET LEAD DOUBLE BEND, 86 CM; PERMANENT PACEMAKER ELECTRODE

Model Number 1457Q/86

Device Problem Failure to Capture (1081)

Patient Problems Syncope (1610); Complete Heart Block (2627)

Event Date 08/26/2019

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The patient was admitted to the hospital due to a loss of consciousness and complete heart block.The patient lost consciousness due to a loss of capture on both the right ventricular (rv) and left ventricular (lv) leads.The output was increased on the rv lead and the vector was changed on the lv lead to successfully induce ventricular capture.The patient was stable following the reprogramming.Related manufacturer report number: 2938836-2019-13475.

• Brand Name: QUARTET LEAD DOUBLE BEND, 86 CM
• 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: 8996402
• MDR Text Key: 157751304
• Report Number: 2017865-2019-13609
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734510189
• UDI-Public: 05414734510189
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 1457Q/86
• Device Lot Number: A000075681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR