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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) NEUTRINO NXT HF; No Match
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) NEUTRINO NXT HF; No Match Back to Search Results
Model Number CDHFA600Q
Device Problems Failure to Convert Rhythm (1540); Under-Sensing (1661)
Patient Problem Arrhythmia (1721)
Event Date 01/29/2024
Event Type  malfunction  
Event Description
It was reported that a patient presented to clinic for follow up.Device interrogation revealed undersensing on the implantable cardioverter defibrillator (icd) triggering vfta.Anti-tachycardia therapy was delivered but did not convert the patient's rhythm.The rhythm was converted via icd shock.Programming changes were performed to resolve the issue.The patient condition was stable.
 
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Brand Name
NEUTRINO NXT HF
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 Key18739305
MDR Text Key336321948
Report Number2017865-2024-33077
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
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 Other Health Care Professional
Type of Report Initial
Report Date 02/20/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2024
Device Model NumberCDHFA600Q
Device Lot NumberP000143646
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/31/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/19/2022
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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