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

Model Number 1458Q/86

Device Problems Failure to Capture (1081); High Capture Threshold (3266)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Discomfort (2330); Palpitations (2467)

Event Date 06/16/2020

Event Type  Injury  

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 presented to the emergency department on (b)(6) 2020 with chest pain and palpitations.Further investigation revealed that the left ventricular lead exhibited high capture thresholds.It was also found that there was diaphragmatic stimulation and failure to capture at max output in different configurations.Device was reprogrammed to only pace in the right ventricle.Lead was then explanted and replaced on (b)(6) 2020.Patient condition was stable after the procedure.

Manufacturer Narrative

Correction: h6 patient code (b)(6) discomfort¿ should be ¿2467 ¿ palpitations".

Event Description

New information received notes that lead dislodgement was the cause of the diaphragmatic stimulation and that the palpitations were caused by diaphragmatic stimulation.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• 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: 10222219
• MDR Text Key: 197269780
• Report Number: 2017865-2020-08526
• 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: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• 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: A000072571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention