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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUICKFLEX MICRO LV LEAD; PERMANENT PACEMAKER ELECTRODE
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUICKFLEX MICRO LV LEAD; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1258T/86
Device Problem Difficult To Position (1467)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/01/2017
Event Type  malfunction  
Event Description
It was reported that the patient presented to the operating room for implant procedure.During procedure, it was observed that the left ventricular lead could not be implanted into the patient.Another was implanted successfully.The patient's condition was stable.
 
Manufacturer Narrative
Analysis was normal.No anomalies were found.
 
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Brand Name
QUICKFLEX MICRO LV LEAD
Type of Device
PERMANENT PACEMAKER ELECTRODE
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
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6722343
MDR Text Key80331111
Report Number2017865-2017-06696
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 08/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2019
Device Model Number1258T/86
Device Lot NumberA000024633
Other Device ID Number05414734502610
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/24/2016
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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