MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ZEPHYR XL DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 5826

Device Problem Difficult to Remove (1528)

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

Event Date 12/01/2023

Event Type  malfunction  

Event Description

It was reported the patient was presented to the hospital for a scheduled implant procedure.During procedure, the set screw at the pacemaker header was difficult to release and disconnect the right atrial (ra) lead.The physician noted that the set screw was blocked due to an adhesive material applied at the connector end of the ra lead.Upon several attempts, the setscrew was removed and the ra lead was disconnected from the pacemaker header.The pacemaker was successfully explanted and replaced on 1 dec 2023.The patient had no adverse consequences.

Manufacturer Narrative

The reported event of difficulty untightening atrial setscrew to remove the atrial lead and difficulty removing the atrial lead after the setscrew was untightened was confirmed.Analysis revealed a large amount of calcified blood covering the top of the connector block and the connector block threads.This indicated the setscrew inset where the wrench inserts into was most likely also filled with calcified blood and blocking the wrench insertion into the setscrew inset.This prevented the physician from untightening the setscrew.The atrial lead was still difficult to remove after the removal of the setscrew due to calcified blood inside the entire atrial connector port.The calcified blood had bonding effects to the lead¿s outer insulation preventing lead removal.In conclusion, the best approach was taken during procedure by breaking apart the header around the lead in order to remove the lead.No other anomalies were seen.

• Brand Name: ZEPHYR XL DR
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 18405313
• MDR Text Key: 331489084
• Report Number: 2017865-2023-95590
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734501620
• UDI-Public: 05414734501620
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880086
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2010
• Device Model Number: 5826
• Device Lot Number: 2710965
• 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: 12/01/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 03/26/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2008
• 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: RIGHT ATRIAL LEAD; RIGHT VENTRICULAR LEAD
• Patient Age: 94 YR
• Patient Sex: Female
• Patient Weight: 40 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White