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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) FRONTIER II IMPLANTABLE PACEMAKER PULSE GENERATOR

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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) FRONTIER II IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5596
Device Problem Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/04/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during a lead repositioning procedure, the lead was unable to be fit into the device. The device was explanted and replaced. The patient was stable during and post-procedure.
 
Manufacturer Narrative
(b)(4).
 
Event Description
New information received indicates that the connection problem was due to a set screw issue.
 
Manufacturer Narrative
The reported inability to tighten the lv set screw was confirmed in the laboratory. Visual inspection identified septum material inside the lv screw hex cavity. This material prevented full insertion of the torque driver in the hex cavity and resulted in difficulty tightening the set screw.
 
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Brand NameFRONTIER II
Type of DeviceIMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6299075
MDR Text Key66604488
Report Number2938836-2017-13509
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeCH
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 01/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2016
Device Model Number5596
Device Lot NumberS000005593
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/26/2015
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: 02/02/2017 Patient Sequence Number: 1
Treatment
(B)(4)
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