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

Model Number 1458Q/86

Device Problems Difficult to Insert (1316); Obstruction of Flow (2423); Failure to Advance (2524)

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

Event Date 02/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during an attempted implant, the lead encountered resistance preventing the full advancement of the distal lead body into the targeted vein.Multiple attempts were made to reposition the outer guide sheath to facilitate advancing the lead.Lead lumen became obstructed, and multiple attempts were made to flush the lumen of the lead with no success.The decision was made to replace the lead.The patient tolerated the procedure well without complication or adverse event.

Manufacturer Narrative

The reported field event of an inability to advance the lead through the patient¿s vein and an inability to flush the lead lumen was confirmed in the laboratory.Visual inspection found ptfe coating and blood on the coil.A guidewire insertion test, flushing test, and insertion test were all performed successfully.The ring electrode dimensions and s-curve height were measured and met all specifications.The cause of the field event was ptfe coating and blood in the coil.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6402314
• MDR Text Key: 70097920
• Report Number: 2938836-2017-18320
• 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: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 1458Q/86
• Device Lot Number: A000008330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2015
• 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 Age: 80 YR