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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT NEUTRINO NXT DR; No Match
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ABBOTT NEUTRINO NXT DR; No Match Back to Search Results
Model Number CDDRA600Q
Device Problems Over-Sensing (1438); Pacing Problem (1439); Pacing Asynchronously (1441)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2024
Event Type  malfunction  
Event Description
During a remote follow-up, far r oversensing, automatic mode switch (ams) and pacemaker mediated tachycardia (pmt) were observed on the device.Technical support was contacted and the device was reprogrammed to resolve the event.The patient was stable and will continue to be monitored.
 
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Brand Name
NEUTRINO NXT DR
Type of Device
No Match
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer Contact
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key19217352
MDR Text Key341438069
Report Number2017865-2024-40105
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05415067034335
UDI-Public(01)05415067034335(10)S000079037(17)221031
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2022
Device Model NumberCDDRA600Q
Device Lot NumberS000079037
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/16/2024
Initial Date FDA Received04/30/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/21/2020
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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