MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD QUICKSITE XL LV; PERMANENT PACEMAKER ELECTRODE

Model Number 1058T/86

Device Problem Unstable (1667)

Patient Problem Irritation (1941)

Event Date 11/20/2014

Event Type  Injury  

Event Description

It was reported that the patients leads were wrapped behind the pulse generator and had become loose.The leads were irritating the skin on the inside of the pocket.The pocket was opened and the leads were re-wrapped and secured underneath the device.

Manufacturer Narrative

(b)(4).

• Brand Name: QUICKSITE XL LV
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: jennie hamel ; 15900 valley view court; sylmar, CA 91342 ; 8184933462
• MDR Report Key: 4392593
• MDR Text Key: 5368082
• Report Number: 2017865-2015-01552
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• 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/86
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z1482
• Patient Sequence Number: 1
• Treatment: 330-258 (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR