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

Model Number 1458Q/86

Device Problem Over-Sensing (1438)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 01/15/2020

Event Type  malfunction  

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

Related manufacturer reference number: 2017865-2020-00921 it was reported that the cardiac resynchronization therapy defibrillator and left ventricular lead exhibited continued phrenic nerve stimulation, despite multiple vector testing, and non-sustained oversensing episodes.No intervention was performed, and the device and lead remained implanted.The patient was stable.

Event Description

Additional information received noted that the patient followed up in clinic on 2/10/2020.Upon investigation, it was noted there were a total of 49 right ventricular over sensing episodes recorded by the defibrillator.Programming changes were recommended but the attending doctor did not want to make these changes as he felt it may not be sensitive enough to detect ventricular fibrillation.The left ventricular lead was tested for the presence of phrenic nerve stimulation.The phrenic nerve stimulation was not reproduced.It was suspected the patient was experiencing the phrenic nerve stimulation during the auto capture test, so the device was reprogrammed.The patient was stable and would be monitored.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 9624963
• MDR Text Key: 176270715
• Report Number: 2017865-2020-00920
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: A000072793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 01/23/2020
• Supplement Dates Manufacturer Received: 02/10/2020
• Supplement Dates FDA Received: 02/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2019
• 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