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

Model Number 7122Q/58

Device Problems Retraction Problem (1536); Low impedance (2285); Capturing Problem (2891)

Patient Problems Discomfort (2330); Cardiac Perforation (2513)

Event Date 08/19/2023

Event Type  Injury  

Event Description

It was reported that the patient presented to the emergency department with sharp left chest wall pain.Device interrogation showed a decrease in pacing impedance and high capture threshold.A computed tomography (ct) was performed showing right ventricular (rv) lead perforation; no effusion was seen.An rv lead revision was performed on (b)(6) 2023 but the helix would not retract or turn.The procedure was stopped and the patient was transferred to another hospital.The patient was in stable condition before, during, and after the procedure.It was later noted that the patient did not want to undergo another procedure, and was discharged.The device is programmed off.

• 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: 17711425
• MDR Text Key: 322967159
• Report Number: 2017865-2023-42552
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503174
• UDI-Public: 05414734503174
• 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: 09/08/2023

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: 7122Q/58
• Device Lot Number: A000144231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/19/2023
• Initial Date FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2023
• 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: GALLANT ICD; TENDRIL RV LEAD
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female