MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. FRONTIER II; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number 5596

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Inadequately (1442)

Patient Problems Syncope (1610); Skull Fracture (2077); Brain Injury (2219)

Event Date 06/09/2017

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer report number: 2017865-2017-08113.The patient presented to the emergency room with presyncope and syncope.The left ventricular (lv) lead impedance had increased and there were asystolic episodes that resulted in noise and oversensing.The device was reprogrammed to resolve the event and the patient was discharged.The next day, the patient returned due to presyncope and syncope that resulted in a fall with right thoracic trauma and a cranioencephalic injury.A ct was performed and a temporal skull fracture was detected.The lv lead displayed noise that resulted in a loss of pacing and syncope.The device was reprogrammed and the lv lead was deactivated and remains implanted.The patient will continue to be monitored.

Event Description

Additional information was received indicating that the patient's condition worsened due to the device pacing in vvi mode; the patient required biventricular resynchronization.The device and left ventricular lead were explanted and replaced.Further information has been requested but not yet received.

Event Description

Additional information was received indicating that the patient's condition worsened due to the device pacing in vvi mode; the patient required biventricular resynchronization.The device and left ventricular lead were explanted and replaced and the patient was stable.

• Brand Name: FRONTIER II
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6796773
• MDR Text Key: 82772008
• Report Number: 2017865-2017-08111
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2010
• Device Model Number: 5596
• Device Lot Number: 2913261
• Other Device ID Number: 05414734006941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2008
• 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: QUICKFLEX MICRO (SN (B)(4))
• Patient Outcome(s): Hospitalization; Other; Required Intervention