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 Retraction Problem (1536); Failure to Advance (2524); Capturing Problem (2891); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923); Impedance Problem (2950)

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

Event Date 12/28/2023

Event Type  Injury  

Event Description

It was reported that the patient presented for a follow-up in clinic.It was noted that the right ventricular (rv) lead had high capture thresholds, device sensing issues in the form of r-wave amplitude variation, and varying low voltage impedance.A chest x-ray confirmed the rv lead was dislodged.The patient was asymptomatic.Upon trying to reposition the rv lead, the physician encountered difficulties when trying to retract the helix, but it eventually did retract.The physician then encountered further difficulties when the stylet could not be advanced in rv lead.The rv lead was explanted and replaced.The patient was stable throughout the procedure.

Manufacturer Narrative

The reported events were lead dislodgement, unacceptable threshold, r-wave amp variation, varying low voltage impedance, helix mechanism issue, and failure to advance stylet.As received, a complete lead was returned in one piece with the helix found retracted and clogged with blood/ tissue.The reported event of helix mechanism issue and stylet could not be fully inserted/removed were confirmed.The cause of the helix and stylet issue was traced to the helix being clogged with blood/tissue and the inner coil being clogged with blood respectively.The reported events of unacceptable threshold, r-wave amp variation, varying low voltage impedance were not confirmed.Analysis was normal, 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: 18509523
• MDR Text Key: 332869273
• Report Number: 2017865-2024-01072
• 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: 03/12/2024

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 Operator: Health Professional
• Device Model Number: LDA210Q/58
• Device Lot Number: A000146049
• 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: 01/04/2024
• Initial Date FDA Received: 01/13/2024
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2023
• 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 HF; MRI COND TENDRIL LEAD; QUARTET LEADS
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 165 KG