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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT HF; No Match
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT HF; No Match Back to Search Results
Model Number CDHFA500Q
Device Problems Under-Sensing (1661); Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2024
Event Type  malfunction  
Event Description
It was reported that a patient presented remotely via merlin.Net.Review of the transmission revealed ventricular undersensing during a non-sustained ventricular tachycardia and vt-1 episode due to r-wave amplitude variation.No changes or interventions were reported.The patient condition was not known.
 
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Brand Name
GALLANT HF
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 Key18960378
MDR Text Key338374247
Report Number2017865-2024-35651
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05415067032010
UDI-Public05415067032010
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 Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCDHFA500Q
Device Lot NumberA000149993
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/04/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/06/2023
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
OPTISURE RV LEAD; QUARTET LV LEAD; TENDRIL RA LEAD
Patient Age68 YR
Patient SexMale
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