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

Model Number 1458Q/86

Device Problems Intermittent Capture (1080); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)

Patient Problems Muscle Stimulation (1412); Syncope (1610)

Event Date 04/13/2015

Event Type  Injury  

Event Description

It was reported that the patient presented to the emergency room with symptoms of syncope and diaphragmatic stimulation.Upon device interrogation, the left ventricular lead exhibited an increase in thresholds and intermittent capture.A chest x-ray confirmed that the lead had dislodged.The lead was explanted and replaced successfully.The patient was doing well post procedure.

Manufacturer Narrative

(b)(4).

• 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: 4842512
• MDR Text Key: 5912809
• Report Number: 2017865-2015-07716
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 1458Q/86
• Device Lot Number: A000002460
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2015
• Initial Date FDA Received: 06/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2015
• 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
• Treatment: 7122Q/65, BPA033421
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR