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

Model Number CDHFA500Q

Device Problem Failure to Convert Rhythm (1540)

Patient Problem Arrhythmia (1721)

Event Type  Injury  

Event Description

It was reported, that the patient presented to the intensive care unit.The patient was very sick in heart failure.That was unrelated to the implantable cardioverter defibrillator (icd) system.Upon interrogation, it was noted, that the icd delivered multiple unsuccessful shocks that were appropriate.The patient was in normal sinus rhythm, when the field representative arrived.Programming changes were made.The patient remained in the intensive care unit post changes.

• 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: 18708210
• MDR Text Key: 335405125
• Report Number: 2017865-2024-22691
• Device Sequence Number: 1
• Product Code: NIK
• 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
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDHFA500Q
• Device Lot Number: S000087896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• 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: 1458Q/86 QUARTET LEADS; 2088TC/52 TENDRIL LEADS; 7120Q/65 DURATATACY MRI LEADS
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Male