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

Model Number 1458Q/75

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Swelling (2091); Thrombosis (2100); Stenosis (2263)

Event Date 01/29/2015

Event Type  Injury  

Event Description

It was reported that the patient was experiencing left arm swelling.A subclavian vein stenosis with thrombosis was observed.The device was explanted on (b)(6) 2015.It was noted that the patient underwent venoplasty and stent placement in the subclavian vein.The patient was given a life vest until re-implant is evaluated.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.Device evaluation anticipated, but not yet begun.

• Brand Name: QUARTET
• 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: 4633484
• MDR Text Key: 5572985
• Report Number: 2017865-2015-03735
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: 1458Q/75
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/18/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 62 YR