MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number LDA210Q/58

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

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

Event Date 03/08/2024

Event Type  Injury  

Event Description

It was reported that patient's right ventricular (rv) lead exhibited loss for capture.It was also noted that the lead was dislodged.During lead revision procedure it was noted that the lead helix was not able to retract.The lead was explanted and replaced.There were no patient consequences.

Manufacturer Narrative

The reported events of lead dislodgement and failure to capture was not confirmed.The reported event of a helix mechanism issue was confirmed.As received, a complete lead was returned in one piece with extended helix and clogged with blood.X-ray examination of the helix mechanism found no anomalies or distortion of the helix or inner coil that would have contributed to helix issues reported in the field.After cleaning and applying torque directly to the connector pin, the helix was able to retract and extend.The measured full helix extension length was within product specification.Electrical testing did not find any indication of conductor fractures or internal shorts.The cause of the reported event was isolated to the helix being clogged with blood/tissue.

• Brand Name: OPTISURE 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: 18969974
• MDR Text Key: 338503863
• Report Number: 2017865-2024-35807
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734507325
• UDI-Public: 05414734507325
• 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: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LDA210Q/58
• Device Lot Number: A000135401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/12/2022
• 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: ENTRANT; QUARTET; TENDRIL
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female