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

Model Number 1458Q/86

Device Problem High Capture Threshold (3266)

Patient Problems Undesired Nerve Stimulation (1980); Discomfort (2330)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

This product is registered as a combination product.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 patient experienced phrenic nerve stimulation (pns) and muscle spasms.When the patient presented in clinic for follow up, it was noted that patient had 4 sneezes with excessive force the day when pns was noted.After sneezing the patient felt diaphragmatic stimulation for about 5 minutes, and then it was gone.Device interrogation revealed high capture threshold on left ventricular (lv) lead.The patient did not feel any phrenic nerve stimulation throughout the interrogation.When tested at higher lv amplitude, phrenic nerve stimulation was noted.Programming changes were made.The patient will be monitored remotely.The patient was stable before, during, and after interrogation.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 10331955
• MDR Text Key: 200595001
• Report Number: 2938836-2020-07650
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: A000088355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2019
• 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