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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT NEUTRINO NXT DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ABBOTT NEUTRINO NXT DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CDDRA600Q
Device Problems Over-Sensing (1438); Pacing Problem (1439)
Patient Problem Fatigue (1849)
Event Date 02/09/2023
Event Type  malfunction  
Event Description
During an in clinic follow up, far field r wave oversensing resulting in inappropriate mode switching was observed on the device.It was reported the patient experienced fatigue.Technical support was contacted and recommended reprogramming to resolve the event.The device was reprogrammed.The patient was stable.
 
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Brand Name
NEUTRINO NXT DR
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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 Key16817433
MDR Text Key314040872
Report Number2017865-2023-18493
Device Sequence Number1
Product Code NIK
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 04/26/2023
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 Model NumberCDDRA600Q
Device Lot NumberP000155416
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/05/2023
Initial Date FDA Received04/26/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/10/2022
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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