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 Difficult to Fold, Unfold or Collapse (1254); Retraction Problem (1536); Device Sensing Problem (2917)

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

Event Date 06/02/2023

Event Type  Injury  

Event Description

It was reported that the patient presented for remote follow up via merlin.Net.A review of the transmission revealed a decrease in sensing exhibited by the right ventricular lead.The physician attempted to revise the lead; however, the helix was slow to retract and failed to redeploy upon repositioning.The lead was explanted and replaced.There were no patient consequences.

Manufacturer Narrative

The reported events were helix mechanism issue and r-wave amplitude variation.As received, a complete lead was returned in one piece.The reported event of helix mechanism issue was confirmed.Visual examination of the lead found the helix was retracted and clogged with blood/tissue.X-ray examination of the lead found the inner coil in the connector region was over torqued due to procedural damage.After the lead was cut and cleaned, the torque was applied directly to the inner coil, the helix was able to extend and retract.The measured full helix extension length was within specification.The cause of the reported event of helix mechanism issue was due to the over torqued inner coil in the connector region and the helix clogged with blood/tissue.The reported event of r-wave amplitude variation was not confirmed.Visual and x-ray examination of the lead did not find any anomalies except for procedural damage.Electrical tests did not find any indication of conductor fractures or internal shorts.

• 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: 17174084
• MDR Text Key: 317625974
• Report Number: 2017865-2023-23810
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503341
• UDI-Public: 05414734503341
• 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: 07/25/2023

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: 7122Q/65
• Device Catalogue Number: 7122Q-65
• Device Lot Number: A000134661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 07/18/2023
• Supplement Dates FDA Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2022
• 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: GALLANT; QUARTET
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male