MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT HF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CDHFA500Q

Device Problem Over-Sensing (1438)

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

Event Date 01/29/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented remotely via merlin.Net.Upon review, the implantable cardioverter defibrillator exhibited post paced t-wave over-sensing.No intervention was performed.No patient consequences.

Event Description

New information notes that the implantable cardioverter defibrillator exhibited post paced t wave over-sensing episodes again.No intervention was performed.No patient consequences.

Event Description

New information received notes that programming changes were made prior to the most recent post-paced t-wave over-sensing event to resolve the last event.Programming changes were made again to resolve the most recent event.There were no patient consequences.

Event Description

New information notes that the implantable cardioverter defibrillator exhibited post paced t wave over-sensing episodes again.No intervention was performed.No patient consequences.

• Brand Name: GALLANT HF
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 16453387
• MDR Text Key: 310354067
• Report Number: 2017865-2023-11322
• 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,Followup,Followup,Followup
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: CDHFA500Q
• Device Catalogue Number: CDHFA500Q
• Device Lot Number: S000084721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2021
• 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: LEFT VENTRICLE LEAD; RIGHT ATRIAL LEAD; RIGHT VENTRICLE LEAD
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 77 KG