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

Model Number 1156T/86

Device Problems Misconnection (1399); Over-Sensing (1438)

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

Event Date 07/11/2017

Event Type  malfunction  

Event Description

It was reported that the asymptomatic patient presented for a three month implant follow-up.It was noted that the left ventricular lead exhibited noise in the right ventricular channel resulting in the recording of inappropriate high ventricular rate episodes.During initial implant of the pulse generator, the right ventricular and left ventricular leads were reversed and connected into the incorrect ports.The noise was not reproducible in the clinic with isometric and pocket manipulation testing.The clinician reprogrammed the device.On (b)(6) 2017 the patient came in for an unrelated surgery.Upon interrogation, the left ventricular lead was still exhibiting noise, resulting in high ventricular rate episodes.The noise was not reproducible in clinic with isometric and pocket manipulation testing.All other electrical measurements were normal.On (b)(6) 2017 the device was reprogrammed to resolve the issue.

• Brand Name: QUICKFLEX LV LEAD
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6752694
• MDR Text Key: 81364758
• Report Number: 2017865-2017-07271
• 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: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Model Number: 1156T/86
• Device Lot Number: 3141772
• Other Device ID Number: 05414734502023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2010
• 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
• Patient Age: 85 YR