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

Model Number CDHFA500Q

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Discomfort (2330)

Event Date 01/24/2024

Event Type  Injury  

Event Description

It was reported that the patient presented in the clinic with pocket infection, erosion, wound dehiscence history and sepsis at the implanted device pocket site.Also, the device pocket was swollen and discolored and the patient was complaining of pocket discomfort.The physician explanted and replaced the entire implantable cardioverter-defibrillator (icd) system the patient was in stable condition throughout the procedure.

Manufacturer Narrative

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.Review of the sterilization records confirmed normal sterilization cycles for the products.The cause of infection could not be determined.

• 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: 18728361
• MDR Text Key: 335703503
• Report Number: 2017865-2024-32941
• 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,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CDHFA500Q
• Device Lot Number: S000091477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Ethnicity: Hispanic
• Patient Race: White