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

Model Number 1258T/86

Device Problems Difficult to Insert (1316); Device Operates Differently Than Expected (2913)

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

Event Date 10/31/2017

Event Type  malfunction  

Event Description

It was reported that the patient presented for initial implant procedure.During the procedure, there was difficulty removing the guidewire from the left ventricular lead after multiple repositioning attempts.The physician noted that the texture of the lead was not normal.The lead was removed and replaced.Upon implanting the replacement lead, the new left ventricular lead exhibited high capture thresholds.Repositioning was attempted but the measurements were not ideal.The lead was replaced.Patient was stable.

Manufacturer Narrative

The damage found was sustained during the surgical procedure.The lead was otherwise normal.

• Brand Name: QUICKFLEX MICRO 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: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7025557
• MDR Text Key: 92689069
• Report Number: 2017865-2017-34500
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 1258T/86
• Device Lot Number: A000038788
• Other Device ID Number: 05414734502610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2017
• 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