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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC. FRONTIER II IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
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  
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.
 
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.
 
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Brand NameFRONTIER II
Type of DeviceIMPLANTABLE 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 Key6796773
MDR Text Key108186159
Report Number2017865-2017-08111
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received08/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2010
Device Model Number5596
Device Lot Number2913261
Other Device ID Number05414734006941
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/12/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/16/2017 Patient Sequence Number: 1
Treatment
QUICKFLEX MICRO (SN (B)(4))
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