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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FRONTIER II IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5596
Device Problems Pacemaker Found in Back-Up Mode (1440); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/08/2017
Event Type  Injury  
Event Description
It was reported that the non-dependent patient presented to the hospital for a routine checkup. During interrogation the pulse generator was found to be in back-up vvi mode due to low battery voltage. The device had experienced a diagnostic issue. The device was explanted and replaced. The patient's condition was stable post procedure.
 
Manufacturer Narrative
The reported backup operation with the device was confirmed in the laboratory and was due to low battery voltage. The low battery voltage was due to normal battery depletion.
 
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Brand NameFRONTIER II
Type of DeviceIMPLANTABLE PACEMAKER PULSE GENERATOR
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
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6549487
MDR Text Key74563211
Report Number2017865-2017-03224
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeIN
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 07/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2013
Device Model Number5596
Device Lot Number3634244
Other Device ID Number05414734006941
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/02/2012
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: 05/05/2017 Patient Sequence Number: 1
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