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

Model Number CDHFA500Q

Device Problems Over-Sensing (1438); Pacing Problem (1439)

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

Event Date 01/17/2024

Event Type  malfunction  

Event Description

It was reported that a patient presented remotely with far r wave over-sensing noted on the atrial channel resulting in inappropriate automatic mode switch.Corrective programming changes were recommended.No adverse patient consequences were reported.

• 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: 19199203
• MDR Text Key: 341360210
• Report Number: 2017865-2024-39929
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2024
• 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: P000157104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/05/2022
• 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 LEADS; QUARTETLEADS; TENDRILLEADS
• Patient Age: 63 YR
• Patient Sex: Male