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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; Drug eluting permanent left ventricular (lv) pacemaker electrode

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUICKFLEX MICRO LV LEAD; Drug eluting permanent left ventricular (lv) pacemaker electrode Back to Search Results
Model Number 1258T
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Event Description
User facility medwatch received that states the left ventricular lead was explanted due to product performance issue.
 
Manufacturer Narrative
Mdr report #: mw5151206.
 
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Brand Name
QUICKFLEX MICRO LV LEAD
Type of Device
Drug eluting permanent left ventricular (lv) 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
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key18891192
MDR Text Key337510074
Report Number2017865-2024-34804
Device Sequence Number1
Product Code OJX
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/12/2024
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? Yes
Device Operator Health Professional
Device Model Number1258T
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/12/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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