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

Model Number 1458Q/92

Device Problems Failure to Capture (1081); High impedance (1291); Therapy Delivered to Incorrect Body Area (1508); Device Dislodged or Dislocated (2923)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 04/17/2020

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 the patient presented to the emergency room with right phrenic nerve stimulation from their left ventricular lead.Interrogation and x-ray confirmed that the left ventricular lead had dislodged.The lead was turned off and the patient was in stable condition.

Event Description

Additional information: due to the dislodgement, there was also high and out of range capture threshold and loss of capture.The lead was explanted and replaced, and the patient was in stable condition.

Event Description

Correction - b5 in previous report mentioned high and out of range capture threshold, when it should have said high and out of range lead impedance.

• 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: 9996938
• MDR Text Key: 188872418
• Report Number: 2017865-2020-05375
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503358
• UDI-Public: 05414734503358
• 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: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 1458Q/92
• Device Catalogue Number: 1458Q-92
• Device Lot Number: A000053058
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 116