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 Fracture (1260); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923)

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

Event Date 02/01/2024

Event Type  Injury  

Event Description

It was reported that the patient presented remotely via merlin.Net.Upon review, it was found that patient's right ventricular (rv) lead exhibited r wave amplitude variation.It was further noted from x-ray that the lead was dislodged.No intervention was done.There were no patient consequences.

Event Description

New information received notes that the lead was explanted and replaced.The patient was stable.

Manufacturer Narrative

The reported events of lead dislodgement, lead sensing problem, and fracture were not confirmed.As received, a complete lead was returned in one piece with the lead helix retracted and clogged with blood.After cleaning and applying torque directly to the connector pin, the helix was able to be extended and retracted.The measured full helix extension length was within product specification.Visual and x-ray examination did not find any anomalies.Electrical testing did not find any indication of conductor fractures or internal shorts.No anomalies were found.

• 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: 18792750
• MDR Text Key: 336372307
• Report Number: 2017865-2024-33592
• Device Sequence Number: 1
• Product Code: NVY
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2024

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 Model Number: LDA210Q/58
• Device Lot Number: A000149314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 03/14/2024; 04/16/2024
• Supplement Dates FDA Received: 04/01/2024; 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male