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 Type  malfunction  

Event Description

It was reported that the patient presented in clinic for generator changeout procedure.During procedure, it was found that the new implantable cardioverter defibrillator (icd) header set screw on the right ventricular port was unable to engage with the lead.The icd was not implanted and an alternate near at hand was implanted instead on (b)(6) 2023.Patient condition was stable.

Manufacturer Narrative

The reported field event set screw anomaly could not be confirmed.The device was returned in one piece for analysis.A malfunction based on analysis was found.Visual inspection of the header attachment area detected discoloration.All set screws were able to latch and secure test leads normally.Telemetry, impedance, sensing, pacing, and high voltage (hv) output functions of the device were normal with no other anomalies found.A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

Manufacturer Narrative

The reported field event set screw anomaly could not be confirmed.The device was returned in one piece for analysis.A malfunction based on analysis was found.Visual inspection of the header attachment area detected discoloration.All set screws were able to latch and secure test leads normally.Telemetry, impedance, sensing, pacing, and high voltage (hv) output functions of the device were normal with no other anomalies found.

• 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: 18194825
• MDR Text Key: 328828943
• Report Number: 2017865-2023-73065
• 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,Followup
• Report Date: 02/14/2024

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: A000147761
• 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: 11/02/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: Not provided; 02/14/2024
• Supplement Dates FDA Received: 02/14/2024; 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2023
• 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
• Treatment: OPTISURE MRI; TENDRIL
• Patient Age: 66 YR
• Patient Sex: Male