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

Model Number 1058T/75

Device Problems Capturing Problem (2891); Output Problem (3005); High Capture Threshold (3266)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2018

Event Type  malfunction  

Manufacturer Narrative

Also see previously reported # 2017865-2016-00874.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 for a follow up in clinic.Functional but high ventricular output was noted on the left ventricular lead and the patient had a functional but advisory right ventricular riata lead.The leads were explanted and replaced during a routine generator change due to elective replacement indicator (eri).The patient was stable.

• Brand Name: QUICKSITE XL LV
• 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 ; 8184932577
• MDR Report Key: 8408814
• MDR Text Key: 138414886
• Report Number: 2017865-2019-03602
• Device Sequence Number: 1
• Product Code: OJX
• 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: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2010
• Device Model Number: 1058T/75
• Device Lot Number: 0002114646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2007
• 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: 1580/60, (B)(4)
• Patient Outcome(s): Required Intervention