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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 Problem Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2022
Event Type  malfunction  
Event Description
It was reported that the patient presented for a generator change procedure.During the procedure, it was noted that the left ventricular lead could not be screwed into the left ventricular port of the implantable cardioverter defibrillator because the set screw appeared to be missing.The device was removed and replaced.The patient was in stable condition.
 
Event Description
It was reported that the patient presented for a generator change procedure.During the procedure, it was noted that the left ventricular lead could not be screwed into the left ventricular port of the implantable cardioverter defibrillator because the set screw appeared to be missing.The device was removed and replaced.The patient was in stable condition.
 
Manufacturer Narrative
The reported event of a missing set screw could not be confirmed.No set screws were missing from the header.Visual inspection of the header found the left ventricular (lv) set screw to be dislodged from the set screw bore.The dislodged set screw is due to over loosening the set screw.Test leads were able to be inserted, secured, and loosened normally in all chambers using the received set screws.
 
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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
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key13472027
MDR Text Key285170165
Report Number2017865-2022-02749
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,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2023
Device Model NumberCDHFA500Q
Device Catalogue NumberCDHFA500Q
Device Lot NumberS000084974
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/19/2022
Initial Date FDA Received02/07/2022
Supplement Dates Manufacturer Received03/11/2022
Supplement Dates FDA Received03/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
MEDTRONIC 5086/45 LEAD; MEDTRONIC 6935M/62 LEAD; QUARTET
Patient Age77 YR
Patient SexMale
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