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

Model Number CDHFA500Q

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

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

Event Date 04/04/2023

Event Type  Injury  

Event Description

It was reported that a patient presented with an infection noted on the patient's implantable cardiovert defibrillator.The device was explanted and replaced on (b)(6) 2023.The patient was stable throughout.

Event Description

New information received notes that the patient exhibited wound dehiscence on the patient's device.It was unknown if cultures of the pocket were taken.

Manufacturer Narrative

A device history record (dhr) review was performed and review of the sterilization records confirmed normal sterilization cycles for the products.The device met specifications prior to leaving abbott manufacturing facilities.The product was returned and visual inspection was normal.Interrogation of the device revealed it was above elective replacement indicator (eri) when received.Based on this information, the device was found to communicate appropriately with a merlin programmer and has not reached the elective replacement indicator (eri).The cause of infection could not be traced to the device.Correction: b1: field should be marked adverse event only.Correction: b2: field should reflect adverse event of intervention and infection adverse event.Correction: h1: field should be marked "serious injury".

• 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: 16781462
• MDR Text Key: 313713680
• Report Number: 2017865-2023-18073
• 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: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDHFA500Q
• Device Catalogue Number: CDHFA500Q
• Device Lot Number: P000154400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 04/20/2023; 05/24/2023
• Supplement Dates FDA Received: 05/09/2023; 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2022
• 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.; RIGHT ATRIAL LEAD.
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 85 YR
• Patient Sex: Male