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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT NEUTRINO NXT HF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ABBOTT NEUTRINO NXT HF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CDHFA600Q
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Pocket Erosion (2013)
Event Date 03/24/2023
Event Type  Injury  
Event Description
During an in-clinic follow-up, a device migration resulting in a pocket erosion was observed.A revision procedure was performed and the device was successfully repositioned in the pocket.The patient was in stable condition.
 
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Brand Name
NEUTRINO NXT HF
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 Key16694738
MDR Text Key312853808
Report Number2017865-2023-16915
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeIT
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 Physician
Type of Report Initial
Report Date 04/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberCDHFA600Q
Device Lot NumberP000157274
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/24/2023
Initial Date FDA Received04/06/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/08/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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