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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL INC. (AFD CAT-SUNNYVALE) GALLANT DR; No Match
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ST. JUDE MEDICAL INC. (AFD CAT-SUNNYVALE) GALLANT DR; No Match Back to Search Results
Model Number CDDRA500Q
Device Problem Failure to Interrogate (1332)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/23/2024
Event Type  malfunction  
Event Description
It was reported that the patient's implantable cardioverter defibrillator exhibited loss of bluetooth telemetry.No intervention was performed.There were no patient consequences.
 
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Brand Name
GALLANT DR
Type of Device
No Match
Manufacturer (Section D)
ST. JUDE MEDICAL INC. (AFD CAT-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer (Section G)
ST. JUDE MEDICAL INC. (AFD CAT-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer Contact
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key18946718
MDR Text Key338308034
Report Number2938836-2024-00003
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05415067032003
UDI-Public05415067032003
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/20/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCDDRA500Q
Device Lot NumberP000158733
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/29/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
DURATA; TENDRIL
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