MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; Permanent defibrillator electrodes

Model Number 7122Q/65

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported that the patient presented with an infection at the implanted device pocket site.The physician explanted the entire system ¿ implantable cardioverter-defibrillator (icd), right ventricular lead and atrial lead due to infection.The patient condition was unknown.

Manufacturer Narrative

Further information requested but was not received.

Manufacturer Narrative

Correction: please retract this report 2017865-2024-39834 as the the infection is not related to the implant site or product as the infection occurred due to another factor or source.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: Permanent defibrillator electrodes
• 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: 19191268
• MDR Text Key: 341138640
• Report Number: 2017865-2024-39834
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503341
• UDI-Public: (01)05414734503341(10)A000101897(17)230930
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P950022
• 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
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 7122Q/65
• Device Lot Number: A000101897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/10/2020
• 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: 68 YR
• Patient Sex: Male