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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; PERMANENT PACEMAKER ELECTRODE
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1458Q/86
Device Problem Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/09/2018
Event Type  malfunction  
Event Description
It was reported the patient presented for initial implant of the left ventricular lead.During the procedure, there was difficulty positioning the lead in the target blood vessel.The guidewire became stuck in the lead, and the lead and guidewire were removed and replaced.The patient was stable before, during, and after surgery.
 
Manufacturer Narrative
The damage found was sustained during procedure.The lead was otherwise normal.
 
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Brand Name
QUARTET
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
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key8002667
MDR Text Key125118278
Report Number2017865-2018-15876
Device Sequence Number1
Product Code OJX
UDI-Device Identifier05414734503198
UDI-Public05414734503198
Combination Product (y/n)N
Reporter Country CodeCA
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,Followup
Report Date 12/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2021
Device Model Number1458Q/86
Device Lot NumberA000057916
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/16/2018
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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