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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) NEUTRINO NXT DR; No Match
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) NEUTRINO NXT DR; No Match Back to Search Results
Model Number CDDRA600Q
Device Problems Failure to Interrogate (1332); Incorrect Measurement (1383)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/13/2023
Event Type  malfunction  
Event Description
It was reported that a patient presented with a connection issue noted on the patient's implantable cardioverter defibrillator that was alleged to be either a loss of bluetooth telemetry or a diagnostic issue.No intervention or adverse patient consequences were reported.
 
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Brand Name
NEUTRINO NXT DR
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 Key18433005
MDR Text Key331899098
Report Number2017865-2024-00194
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeAS
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 01/02/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCDDRA600Q
Device Lot NumberP000172567
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/10/2023
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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