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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT DR; No Match
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 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 02/08/2024
Event Type  malfunction  
Event Description
It was reported that the patient exhibited difficulty in pairing their implantable cardioverter defibrillator (icd) to the merlin app.Upon further investigation, it was found that the icd exhibited loss of bluetooth telemetry functionality.No changes were reported.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.(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 Key19008646
MDR Text Key338997488
Report Number2017865-2024-37272
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05415067032003
UDI-Public05415067032003
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,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCDDRA500Q
Device Lot NumberP000159395
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/01/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/09/2022
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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