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

Model Number CDDRA500Q

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

Patient Problems Wound Dehiscence (1154); Fever (1858); Unspecified Infection (1930)

Event Date 10/17/2022

Event Type  Injury  

Event Description

It was reported that the patient presented to the hospital for an unrelated procedure.Upon inspection, it was noted that there was a hole at the implantable cardioverter defibrillator (icd) pocket incision site and the device was exposed.It was noted that the patient had been picking at the incision site.The physician performed a pocket revision.The patient was in stable condition.

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.The cause of infection could not be traced to the device.

Event Description

Related manufacturing reference number: (b)(4).Related manufacturing reference number: (b)(4) new information received indicates that the pocket was infected.The patient presented with an open pocket with pus coming from the opening on 27 oct 2023.The physician decided to prescribe antibiotics and monitor.On 11 nov 2023 the patient presented with a fever and chills.No vegetation was noted on the leads.The dual chamber implantable cardioverter defibrillator, right ventricular and right atrial leads were explanted.The patient was stable.

• Brand Name: GALLANT DR
• 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: 15741360
• MDR Text Key: 303134932
• Report Number: 2017865-2022-44424
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032003
• UDI-Public: 05415067032003
• 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: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: CDDRA500Q
• Device Catalogue Number: CDDRA500Q
• Device Lot Number: S000084901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• 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: LDA210Q/65 OPTISUREMRI LEADS; LPA1200M/52 MRI TENDRILLEAD
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Race: American Indian Or Alaskan Native