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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 Premature Discharge of Battery (1057); Failure to Interrogate (1332)
Patient Problems Muscle Stimulation (1412); Heart Failure (2206)
Event Date 09/13/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient experiencing pocket stimulation and worsening heart failure symptoms presented in hospital. The pulse generator could not be interrogated with multiple programmers. Magnet electrograms revealed the device exhibited premature battery depletion. The device was explanted and replaced on (b)(6) 2016; there were no adverse consequences to the patient. The patient's condition was good during and post procedure.
 
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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
jaime chavez
15900 valley view court
sylmar, CA 91342
8184934022
MDR Report Key6025048
MDR Text Key57247678
Report Number2017865-2016-06542
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
Report Date 09/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2016
Device Model Number5596
Device Lot Number4765251
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/27/2014
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: 10/13/2016 Patient Sequence Number: 1
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