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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 Over-Sensing (1438); Pacing Asynchronously (1441)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2024
Event Type  malfunction  
Event Description
It was reported that the patient's implantable cardioverter defibrillator exhibited one episode of post-sensed t wave oversensing caused by pseudo pseudo fusion.No interventions were performed.The patient was in stable condition.
 
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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 Key19011472
MDR Text Key339009984
Report Number2017865-2024-37278
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05415067034359
UDI-Public(01)05415067034359(10)P000170592(17)250531
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 Nurse
Type of Report Initial
Report Date 04/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCDHFA600Q
Device Lot NumberP000170592
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/11/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/20/2023
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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