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

Model Number 1458Q/86

Device Problems Failure to Capture (1081); Device Dislodged or Dislocated (2923)

Patient Problems Syncope (1610); Fall (1848)

Event Date 10/19/2017

Event Type  Injury  

Event Description

It was reported that the patient was seen in hospital after passing out during a ventricular tachycardia episode; the device appropriately treated the arrhythmia.The left ventricular lead exhibited loss of capture; x-ray revealed the lead was dislodged; the physician suspected that this was due to the patient suffering a fall during the vt episode.The lead was explanted and replaced on (b)(6) 2017.The patient was in stable condition post procedure.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• 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: 7024992
• MDR Text Key: 91807125
• Report Number: 2017865-2017-34492
• 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: 12/06/2017

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 1458Q/86
• Device Lot Number: A000044184
• Other Device ID Number: 05414734503198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR