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 Problems Failure to Capture (1081); Over-Sensing (1438); Retraction Problem (1536); Device Dislodged or Dislocated (2923)

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

Event Type  Injury  

Event Description

It was reported that the patient presented in clinic for a follow up.Device interrogation revealed failure to capture, noise oversensing dislodgement and failure to extent helix on the right ventricular (rv) lead.The physician elected to explant and replace the rv lead.There were no patient consequences.

Manufacturer Narrative

The reported events were lead dislodgement, sensing noise, failure to capture and a helix mechanism issue.As received, a complete lead was returned in one piece with the helix retracted and clogged blood/tissue.The reported events of sensing noise, failure to capture were not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.The reported event of a helix mechanism issue was confirmed.X-ray examination of the lead found the inner coil was over torqued in the connector region consistent with the procedure damage.After cleaning and by applying toque directly to the inner coil, the helix could be extended and retracted.The full helix extension length was measured to be within specification.The cause of the reported event of a helix mechanism issue was isolated to blood/tissue in the helix region and the inner coil over torqued in the connector region consistent with procedure damage.

• 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: 19029497
• MDR Text Key: 339207542
• Report Number: 2017865-2024-37525
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503341
• UDI-Public: (01)05414734503341(10)A000129037(17)250731
• 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,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7122Q/65
• Device Lot Number: A000129037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• 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?: Yes
• Date Device Manufactured: 08/09/2022
• 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: 2088TC/52; CDDRA500Q
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 120 KG