MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM ACTIVE FIXATION; Implantable cardioverter defibrillator (non-CRT)

Model Number 7120/65

Device Problems Signal Artifact/Noise (1036); Break (1069); Failure to Sense (1559); Low impedance (2285)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2024

Event Type  malfunction  

Event Description

It was reported that during a generator change with the new device no sensing was noted, and the pacing impedance went below the lower limit.The physician used a repair kit to repair the lead possibly due to some type of insulation breach.No further anomalies were observed, the device was functioning appropriately.One week post-procedure at in clinic check, noise was detected on a remote transmission.An attempt to reproduce the noise was done but it is unknown if the noise was reproducible.The patient will be monitored remotely.There were no adverse health consequences, the patient was stable.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION
• Type of Device: Implantable cardioverter defibrillator (non-CRT)
• 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: 18833182
• MDR Text Key: 336994836
• Report Number: 2017865-2024-34036
• 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: Physician
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: 7120/65
• Device Lot Number: 3722587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2012
• 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: FORTIFY ASSURA
• Patient Age: 48 YR
• Patient Sex: Female