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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 Difficult to Insert (1316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/19/2023
Event Type  malfunction  
Event Description
It was reported that during implant procedure patient's new left ventricular lead was not able to be implanted.The lead showed resistance while inserting in catheters.The lead was not used and the procedure was completed using an alternate lead on 19 dec 2023.There were no patient 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 Key18437445
MDR Text Key331820660
Report Number2017865-2024-00256
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734503198
UDI-Public05414734503198
Combination Product (y/n)Y
Reporter Country CodeBR
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,Followup
Report Date 02/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1458Q/86
Device Lot NumberA000143456
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/22/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/12/2023
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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