MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/86

Device Problems High impedance (1291); High Capture Threshold (3266)

Patient Problems Muscle Stimulation (1412); Dyspnea (1816)

Event Date 02/04/2020

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

It was reported that the patient presented to clinic after feeling shortness of breath and receiving a vibratory alert from their implantable cardioverter defibrillator.Interrogation revealed that the device was close to elective replacement indication and that the left ventricular lead had high out-of-range impedance.During device reprogramming, it was noted that the lead exhibited variable high threshold, and pocket stimulation in all but one vector.Chest x-ray was performed and did not reveal any apparent abnormalities.The device was reprogrammed, and lead replacement was discussed but not performed.

Manufacturer Narrative

The damage found was sustained during the surgical procedure.  the lead was otherwise normal.

Event Description

Additional information: the lead was explanted and replaced.The patient was in stable condition throughout.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 9746033
• MDR Text Key: 180715441
• Report Number: 2017865-2020-02084
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2020

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: 03/31/2015
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: 3652560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 02/24/2020
• Supplement Dates Manufacturer Received: 05/05/2020; 05/20/2020
• Supplement Dates FDA Received: 05/19/2020; 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention