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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 Capture (1081); Over-Sensing (1438)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that the patient presented in clinic and the implantable cardioverter defibrillator exhibited loss of ventricular capture and r-wave oversesning.Device programming changes were suggested by abbott technical services; however, it was reported that programming changes will be made when patient is back in clinic.Patient was stable throughout the event.
 
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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 Key19024979
MDR Text Key339230976
Report Number2017865-2024-37493
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05415067034359
UDI-Public(01)05415067034359(10)P000176505(17)250731
Combination Product (y/n)N
Reporter Country CodeSF
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 04/02/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCDHFA600Q
Device Lot NumberP000176505
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/14/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/25/2023
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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