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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI QUICKFLEX MICRO LV LEAD
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ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI QUICKFLEX MICRO LV LEAD Back to Search Results
Model Number 1258T/86
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 07/27/2012
Event Type  Injury  
Event Description
It was reported that due to a dissection in the coronary sinus the lead was not able to be implanted.
 
Manufacturer Narrative
This historical complaint is being filed as part of a retrospective review of complaint files in response to a recent fda inspection.There is no change to the actual performance of the product and this report only represents an enhancement to the reporting criteria going forward.
 
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Brand Name
QUICKFLEX MICRO LV LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
15900 valley view ct.
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
15900 valley view ct.
sylmar CA 91342
Manufacturer Contact
cary lawler
15900 valley view ct.
sylmar, CA 91342
8184932621
MDR Report Key4115310
MDR Text Key4703484
Report Number2017865-2014-07634
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/30/2015
Device Model Number1258T/86
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date07/27/2012
Device Age1 MO
Event Location Hospital
Initial Date Manufacturer Received 07/27/2012
Initial Date FDA Received01/13/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2012
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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