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

Model Number CDHFA500Q

Device Problem Incorrect Measurement (1383)

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

Event Type  malfunction  

Event Description

It was reported a patient's implantable cardioverter defibrillator (icd) presented with a diagnostic anomaly.No changes were reported.The patient was stable.

Event Description

New information received notes programming changes were made on the implantable cardioverter defibrillator (icd) to restore normal parameters.The patient was stable.

Manufacturer Narrative

The reported event of no activity data being available was confirmed.Based on the information provided, it was determined that the device was not collecting activity because the calibration phase of the exercise compliance algorithm has not completed.The root cause of the incomplete calibration phase was due to it being interrupted by ongoing af episodes, which prevents the execution of the algorithm.The device is performing per design.

• 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: 17443361
• MDR Text Key: 320228325
• Report Number: 2017865-2023-37361
• 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: 11/03/2023

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: S000089266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 08/11/2023; 10/30/2023
• Supplement Dates FDA Received: 08/15/2023; 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2023
• 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: ATRIAL LEAD; LEFT VENTRICULAR LEAD; RIGHT VENTRICULAR (RV) LEAD
• Patient Age: 80 YR
• Patient Sex: Male