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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT HF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT HF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CDHFA500Q
Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Under-Sensing (1661)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that a patient presented with under-sensing, incorrect measurement, and a marker anomaly noted on the patient's implantable cardioverter defibrillator.No intervention was reported and the patient was stable throughout.
 
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Brand Name
GALLANT 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
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key17113520
MDR Text Key317659846
Report Number2017865-2023-22955
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05415067032010
UDI-Public05415067032010
Combination Product (y/n)N
Reporter Country CodeAS
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
Report Date 06/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCDHFA500Q
Device Catalogue NumberCDHFA500Q
Device Lot NumberP000159895
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/29/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/16/2022
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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