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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. QUICKFLEX MICRO LV LEAD; PERMANENT PACEMAKER ELECTRODE

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ST. JUDE MEDICAL, INC. QUICKFLEX MICRO LV LEAD; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1258T/86
Device Problems Pacing Intermittently (1443); No Pacing (3268)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/15/2017
Event Type  malfunction  
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
Related manufacturer report number: 2938836-2017-32690.During a follow-up, while performing capture testing, there were episodes of no pacing output on the device and there were episodes of varied pacing values.The device was reprogrammed to resolve the event.Further information was not available.
 
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Brand Name
QUICKFLEX MICRO LV LEAD
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer Contact
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key6931819
MDR Text Key89591101
Report Number2017865-2017-32908
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 10/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2013
Device Model Number1258T/86
Device Lot Number3168674
Other Device ID Number05414734502610
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/15/2017
Initial Date FDA Received10/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/12/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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