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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD DOUBLE BEND, 86 CM; Drug eluting permanent left ventricular (lv) pacemaker electrode

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD DOUBLE BEND, 86 CM; Drug eluting permanent left ventricular (lv) pacemaker electrode Back to Search Results
Model Number 1457Q/86
Device Problems Break (1069); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/06/2023
Event Type  malfunction  
Event Description
It was reported the patient presented for implant procedure.During surgery, the stylet had difficulty advancing down the left ventricular (lv) lead and as the stylet was removed, the lv lead broke.The procedure was completed using a different lead.The patient was in stable condition.
 
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Brand Name
QUARTET LEAD DOUBLE BEND, 86 CM
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 Key17999906
MDR Text Key326467601
Report Number2017865-2023-50370
Device Sequence Number1
Product Code OJX
UDI-Device Identifier05414734510189
UDI-Public05414734510189
Combination Product (y/n)Y
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 10/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2024
Device Model Number1457Q/86
Device Lot NumberA000111422
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/24/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
QUADRA ALLURE; TENDRIL STS; TENDRIL STS
Patient Age73 YR
Patient SexFemale
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