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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 Problem Failure to Disconnect (2541)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/06/2017
Event Type  malfunction  
Manufacturer Narrative
Visual inspection of the header revealed that rv set screw was damaged and stripped. It was also noted that top of the rv set screw had some blood and small pieces of septum in it. The cause for the reported issue was related to stripping of the set screw during explant.
 
Event Description
During device replacement, there were difficulties loosening the screw holding the right ventricular lead due to dried blood in the screw head slot. The blood was rinsed out and the lead was removed. The patient was reported to be stable.
 
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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 Key6723917
MDR Text Key108032273
Report Number2017865-2017-06735
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeFI
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
Report Date 10/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2010
Device Model Number5596
Device Lot Number2913168
Other Device ID Number05414734006941
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/11/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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