Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; NO MATCH
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; NO MATCH Back to Search Results
Model Number 1458Q
Device Problems Therapy Delivered to Incorrect Body Area (1508); Low impedance (2285); Capturing Problem (2891)
Patient Problem Discomfort (2330)
Event Type  malfunction  
Event Description
It was reported that a patient presented in-clinic with inappropriate extracardiac stimulation, high capture thresholds, and low pacing impedance noted on the left ventricular lead.No intervention or adverse patient consequences were reported.
 
Manufacturer Narrative
Sus voluntary even report was received.Medwatch: mw5119556.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key17581618
MDR Text Key321516797
Report Number2017865-2023-38829
Device Sequence Number1
Product Code NIK
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1458Q
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/16/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-