MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM ACTIVE FIXATION; DEFIBRILLATION LEAD

Model Number 7120/65

Device Problems Failure to Deliver Shock/Stimulation (1133); Low impedance (2285); Charging Problem (2892)

Patient Problem Arrhythmia (1721)

Event Date 08/20/2022

Event Type  Injury  

Event Description

It was reported that a patient reported to the emergency room due to the right ventricular lead exhibiting a loss of defibrillation therapy.Attempted shocks had failed due to low defibrillation impedance that resulted in a over current detection (ocd) alert.The patient arrhythmia was resolved through external defibrillation.Diagnostic imaging of the lead returned no physical anomalies.Programming changes were made, and the lead was successfully capped on (b)(6) 2022 and replaced.The patient was stable.

Event Description

Related manufacturer report number: 2017865-2022-22454.

Manufacturer Narrative

Correction: h6 impact code previously reported as 'additional surgery', now updated to '4641 - unexpected medical intervention'.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION
• Type of Device: DEFIBRILLATION LEAD
• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15329510
• MDR Text Key: 299002096
• Report Number: 2017865-2022-21974
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 05414734502092
• UDI-Public: 05414734502092
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2010
• Device Model Number: 7120/65
• Device Catalogue Number: 7120-65
• Device Lot Number: 0002141726
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2007
• 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: ELLIPSE VR
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male