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

Model Number 1458QL/86

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 08/14/2020

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

Related manufacturer reference number: 2017865-2020-13009, related manufacturer reference number: 2017865-2020-13012.It was reported that the patient presented in clinic with phrenic nerve stimulation.It was revealed that the patient's left ventricular (lv) lead had a history of inducing phrenic nerve stimulation in the patient.It was further found that the patient's right ventricular (rv) lead had dislodged into the right atrium, causing loss of capture and far p-wave over-sensing.The physician elected to explant and replace both of the leads.The rv lead was explanted and replaced with no complications.A novel lv lead was attempted to be implanted on (b)(6) 2020.During the implant of the novel lv lead, it was found that the lead could not be advanced and was not implanted.Upon implant of a second novel lv replacement lead, it was noted that the competitor's sheath used during the implant of the first novel lv lead had caused cardiac perforation, leading the physician to suspend the implant of a replacement lv lead.The patient was discharged.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 10488135
• MDR Text Key: 205493699
• Report Number: 2017865-2020-13011
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510219
• UDI-Public: 05414734510219
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 1458QL/86
• Device Catalogue Number: 1458QL/86
• Device Lot Number: A000093663
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2020
• 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
• Treatment: QUARTET; TENDRIL
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR