MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT HF; NO MATCH

Model Number CDHFA500Q

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2023

Event Type  malfunction  

Event Description

Related manufacturing reference number: 2017865-2023-93311.Related manufacturing reference number: 2017865-2023-93312.Related manufacturing reference number: 2017865-2023-93313.It was reported that the patient presented for a follow up in clinic.It was noted that the right ventricular (rv), left ventricular (lv), and right atrial (ra) leads were all dislodged due to twiddlers syndrome.The dislodgement was discovered via fluoroscopy.Additionally, due to the dislodgement, it was noted that the rv lead had no capture, device sensing issues in the form of r-wave amplitude variation, and high pacing impedance.The patient was asymptomatic.The plan was to explant and replace all the leads and connect the new leads to the current implantable cardioverter defibrillator (icd), but during the procedure, the physician encountered difficulties when trying to connect the new rv lead to the icd.It was discovered that the set screw of the icd was stripped.Ultimately, the rv, lv, and ra leads, along with the icd were all explanted and replaced successfully.The patient was discharged.

Manufacturer Narrative

The reported field event of set screw anomaly was confirmed.Septum material was observed inside the rv(df4) set screw hex cavity, and the set screw was stripped.This did not allow the set screw to be tightened and secured properly in the field.The issue was consistent with having occurred during the procedure.

• 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 Key: 18217965
• MDR Text Key: 329137461
• Report Number: 2017865-2023-93310
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032010
• UDI-Public: 05415067032010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• 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: 12/27/2023

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 Number: CDHFA500Q
• Device Lot Number: P000161559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 78 KG