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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 5586
Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/22/2018
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 for routine pulse generator replacement. Upon device interrogation prior to the procedure, it was discovered that only basic parameters were available. No battery information could be obtained. The physician had noted that on (b)(6) 2018 the remaining longevity was a year but the device prematurely reached elective replacement indicator on (b)(6) 2018. The device was explanted and replaced. The patient was stable.
 
Event Description
New information receives stated that per physician the battery estimated one year remaining; however, a month later device reached elective replacement indicator. It was also noted that there was no communication with the device. It was mentioned that the battery had one year remaining in (b)(6) 2018 and patient presented in office in eri six months later.
 
Manufacturer Narrative
The reported event of premature battery depletion was not confirmed. Device was received in backup vvi mode, and at eri voltage level. Analysis of device image indicated that the backup operation has occurred post explant due to exposure to cold temperature. The false eri triggered about three months before the explant date which resulted from transient low battery voltage, consistent with high pacing output usage. Longevity assessment was performed based on field settings and it has met the projected longevity.
 
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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
elizabeth boltz
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key8157875
MDR Text Key130164998
Report Number2017865-2018-18790
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,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2009
Device Model Number5586
Device Lot Number0002134101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/11/2008
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: 12/12/2018 Patient Sequence Number: 1
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