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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ENTRANT VR; NO MATCH
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ENTRANT VR; NO MATCH Back to Search Results
Model Number CDVRA300Q
Device Problem Interrogation Problem (4017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that the implantable cardioverter defibrillator was unable to pair due to a possible bluetooth malfunction.There were no patient consequences reported.Further information was requested but not received.
 
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Brand Name
ENTRANT VR
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 Key17733810
MDR Text Key323404215
Report Number2017865-2023-42918
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05415067032836
UDI-Public05415067032836
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2023
Device Model NumberCDVRA300Q
Device Lot NumberS000081085
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/25/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2021
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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