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

Model Number 1158T/86

Device Problem Component Missing (2306)

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

Event Date 11/08/2013

Event Type  malfunction  

Event Description

It was reported that during a routing device change out, the left ventricular lead exhibited a connector sealing ring was missing.The lead was capped and replaced.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.

• Brand Name: QUICKFLEX XL LV LEAD
• 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: cary lawler ; 15900 valley view court; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 3559821
• MDR Text Key: 4052361
• Report Number: 2017865-2014-00994
• Device Sequence Number: 1
• Product Code: NIK
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2010
• Device Model Number: 1158T/86
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/08/2013
• Device Age: 71 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/08/2013
• Initial Date FDA Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z1483
• Patient Sequence Number: 1
• Patient Age: 72 YR