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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 Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/30/2023
Event Type  malfunction  
Event Description
It was reported that the patient presented for a scheduled procedure.During the procedure, the physician was trying to insert the hex wrench into the left ventricular lead port however, the set screw would not engage.A new wrench was attempted and still unable to unscrew.The device was removed and replaced.There were no patient consequences.
 
Manufacturer Narrative
The reported field event of lead connection issue was confirmed.The device was above elective replacement indicator (eri) when received.Analysis revealed the rv (df4) set screw was backed out from its thread as a result of unscrewing the set screw too far and it contained septum material inside the cavity.When the screw was re-engaged with the connector block, the screw operated normally in affixing the test lead to the header.The connection anomaly was consistent with having occurred during the procedure.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.
 
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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 Key18177852
MDR Text Key328628615
Report Number2017865-2023-72770
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 12/14/2023
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 Model NumberCDHFA500Q
Device Lot NumberA000147670
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/30/2023
Initial Date FDA Received11/20/2023
Supplement Dates Manufacturer Received12/13/2023
Supplement Dates FDA Received12/14/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/19/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age28 YR
Patient SexMale
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