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

Model Number CDDRA500Q

Device Problem No Apparent Adverse Event (3189)

Patient Problems Hematoma (1884); Unspecified Infection (1930)

Event Date 12/28/2023

Event Type  Injury  

Event Description

It was reported that the system was extracted due to an infection.The defibrillator did not erode the skin, but redness, a hematoma and a very discernable yellow discharge was observed.The physician believed the infection was not caused by abbott products but by drugs that caused a hematoma which caused infection.The lead did not erode the skin and had no sign of vegetation.The patient was stable.

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.The reported event will continue to be monitored and trended. .

Manufacturer Narrative

Correction: type of investigation corrected from "4114 - device not returned" to "3331 -analysis of production records".

• Brand Name: GALLANT DR
• 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: 18522823
• MDR Text Key: 332973381
• Report Number: 2017865-2024-01319
• 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
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CDDRA500Q
• Device Lot Number: P000176946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2023
• 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
• Treatment: GUI 0276/64 RIGHT VENTRICULAR LEAD.; TENDRIL STS RIGHT ATRIAL LEAD.
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male