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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 Problem Pacemaker Found in Back-Up Mode (1440)
Patient Problem Heart Failure (2206)
Event Date 03/19/2018
Event Type  Injury  
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
It was reported that the patient presented during a follow up in clinic. Upon investigation, it was noted that the pacemaker was found to be in backup vvi mode. The patient did not have any surgical or mri related procedure. The patient had symptoms of heart failure while lying down. Multiple attempts to restore the device failed and the device had not reached elective replacement indicator (eri). Device replacement was suggested. Additional information was not reported.
 
Event Description
New information received on (b)(6) 2018 notes that the device was still in bvvi and no device replacement was performed.
 
Event Description
New information received on 6/15/2018 notes that the device was explanted on (b)(6) 2018. Patient was stable and had recovered.
 
Event Description
New information received on 5/18/2018 notes that the device was explanted. Additional information was not reported.
 
Manufacturer Narrative
The field complaint of backup was confirmed. Device was received in backup mode with battery voltage at end of life (eol) level. Backup mode was triggered due to normal battery depletion. Testing performed after installing new battery and reloading product indicated normal device functionality. Battery longevity was estimated to be normal.
 
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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
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key7431889
MDR Text Key105531272
Report Number2017865-2018-05784
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup,Followup
Report Date 08/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2016
Device Model Number5596
Device Lot Number4875244
Other Device ID Number05414734006941
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/2014
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: 04/15/2018 Patient Sequence Number: 1
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