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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 Therapy Delivered to Incorrect Body Area (1508)
Patient Problem Discomfort (2330)
Event Date 01/18/2024
Event Type  Injury  
Event Description
It was reported that the patient's left ventricular (lv) lead exhibited pectoral stimulation.The lv lead was explanted and replaced.The patient was stable before, during and after the procedure.
 
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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 Key18692060
MDR Text Key335184822
Report Number2017865-2024-22427
Device Sequence Number1
Product Code NIK
Combination Product (y/n)Y
Reporter Country CodeCA
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 02/12/2024
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 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
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/12/2024
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
Treatment
BIOTRONIK.
Patient Outcome(s) Required Intervention;
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