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

Model Number 1458Q/86

Device Problems Partial Blockage (1065); Positioning Failure (1158)

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

Event Date 08/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during implant procedure, the left ventricular lead helix had difficulty extending.The physician attempted to flush the lead but was unsuccessful.The lead was not used and replaced successfully.

Manufacturer Narrative

Final analysis confirmed that it was difficult to insert the stylet into the lead.Dried saline was found at 22.7cm from the connector pin which prevented the stylet to be inserted.

• Brand Name: QUARTET
• 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: jaime chavez ; 15900 valley view court; sylmar, CA 91342 ; 8184934022
• MDR Report Key: 5992246
• MDR Text Key: 56465227
• Report Number: 2017865-2016-06332
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 1458Q/86
• Device Lot Number: A000019553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2016
• 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