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

Model Number 5826

Device Problems Difficult to Remove (1528); Failure to Disconnect (2541)

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

Event Date 02/26/2024

Event Type  malfunction  

Event Description

Related manufacturer reference number: 2017865-2024-35155.It was reported that the patient presented for a generator change procedure.During the procedure, the physician could not remove the right ventricular set screw from the header, which failed to remove the right ventricular lead from the device.The physician cut the lead.A new pacemaker and right ventricular lead were replaced.The patient was in a stable condition.

Manufacturer Narrative

The reported event of the setscrew could not be loosened to remove the lead was confirmed.Final analysis found that as received that calcified blood was filling the setscrew inset.The calcified blood was preventing the wrench from entering and engaging the setscrew inset to untighten the setscrew.Wrenches cannot penetrate the calcified blood.With calcified blood filling the inset all the wrench will do is strip the parts of the inset it comes in contact with.The calcified blood is next removed out of the setscrew inset.A wrench then could be fully inserted into the inset.The setscrew could then be untightened normally, and the stuck lead was removed out of the connector.The blood came through a hole punched through the septum by the user of the torque wrench at time of implant.

• 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: 18919206
• MDR Text Key: 337847625
• Report Number: 2017865-2024-35156
• 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: 03/26/2024

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: 11/30/2010
• Device Model Number: 5826
• Device Lot Number: 2809920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/17/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2009
• 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: 2088TC/58 TENDRIL
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 80 KG