MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR; DEFIBRILLATION LEAD

Model Number 7120Q/58

Device Problem Component Missing (2306)

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

Event Date 02/11/2014

Event Type  malfunction  

Event Description

It was reported that during the implant procedure, the suture sleeve could not be located.The physician removed the lead for inspection, but the sleeve was still not found.X-ray did not reveal that it was in the patient and the patient had no symptoms.The lead was fixed without the sleeve.No further action was taken.

Manufacturer Narrative

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

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
• Type of Device: DEFIBRILLATION LEAD
• 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 ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184932621
• MDR Report Key: 3794741
• MDR Text Key: 17836394
• Report Number: 2938836-2014-10697
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• 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: 01/31/2016
• Device Model Number: 7120Q/58
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2014
• Initial Date FDA Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2013
• 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