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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; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) NEUTRINO NXT HF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CDHFA600Q
Device Problem Delayed Charge Time (2586)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/24/2022
Event Type  malfunction  
Event Description
It was reported a patient presented for an implant procedure on (b)(6) 2022.During procedure, the implantable cardioverter-defibrillator was found to have a long charge time and an alternative device was used.There was no impact to the patient.
 
Manufacturer Narrative
Correction: return not received, appropriate codes inputted.
 
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Brand Name
NEUTRINO NXT HF
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key14575681
MDR Text Key293174485
Report Number2017865-2022-11601
Device Sequence Number1
Product Code NIK
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 Physician
Type of Report Initial,Followup
Report Date 07/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2023
Device Model NumberCDHFA600Q
Device Lot NumberP000135691
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/13/2021
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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