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

Model Number 1458Q/86

Device Problems Bent (1059); Intermittent Capture (1080); Fracture (1260); Device Operates Differently Than Expected (2913); Difficult to Advance (2920); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)

Patient Problems Chest Pain (1776); No Known Impact Or Consequence To Patient (2692)

Event Date 09/15/2017

Event Type  Injury  

Event Description

It was reported that the lead was explanted and replaced for an unknown reason.No further information is available at this time.

Manufacturer Narrative

Correction - date of event was initially reported incorrectly; this report notes the correct date.

Event Description

New information received indicated that the lead was explanted and replaced due to dislodgement.It was noted that during a pvc (premature ventricular contractions) ablation procedure, the lv lead was not functioning properly.Patient had experienced stabbing chest pain that had resolved and patient believed was related to the lv lead.The lv lead noted to have elevated threshold with intermittent capture.During the lead revision, the guidewire would not pass through the lead entirety, suspecting a possible fracture or excessive bending of the lead.There were no complications and patient was discharged in stable condition.

• 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: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7066079
• MDR Text Key: 93161485
• Report Number: 2017865-2017-35160
• 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: other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: 1458Q/86
• Device Lot Number: A000010127
• Other Device ID Number: 05414734503198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 71 YR