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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; No Match
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; No Match Back to Search Results
Model Number 1458Q/86
Device Problem Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/07/2023
Event Type  malfunction  
Event Description
It was reported that the patient presented to the hospital for a scheduled implant procedure.During the procedure, the left ventricular (lv) lead had failed to advance in the catheter due to the catheter being stuck in the lead.The lv lead was then removed and replaced.The patient had no adverse consequences.
 
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Brand Name
QUARTET
Type of Device
No Match
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 Key18211692
MDR Text Key329039050
Report Number2017865-2023-93138
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734503198
UDI-Public05414734503198
Combination Product (y/n)Y
Reporter Country CodeJA
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
Report Date 11/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1458Q/86
Device Lot NumberA000141051
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/07/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/18/2023
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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