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); Contamination of Device Ingredient or Reagent (2901)

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

Event Date 12/06/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented for an explant procedure.During the procedure, the set screw of the pacemaker had a layer of white substance on the setscrew.Moreover, the setscrew was difficult to be removed.Eventually, the pacemaker was explanted and replaced.The patient experienced no consequences.

Manufacturer Narrative

The reported events of difficult to remove, and contamination of device ingredient or reagent were not confirmed.The device was received from the field with battery voltage above elective replacement indicator (eri) level reaching eri during the analysis.Visual inspection of the header found the ventricular septum, ventricular setscrew removed, and ventricular output port damaged by end user.Additionally scanning electron microscopy (sem) analysis of substance near the ventricular port determined to be calcified blood and no contamination or foreign material detected.Electrical analysis performed after replacing the setscrew indicated normal functionality.Longevity assessment was performed, and the device exceeded projected longevity indicating normal battery depletion.

• 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: 18390827
• MDR Text Key: 331285509
• Report Number: 2017865-2023-95565
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

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: 09/30/2012
• Device Model Number: 5826
• Device Lot Number: 3350554
• 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: 12/06/2023
• Initial Date FDA Received: 12/26/2023
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2011
• 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
• Patient Age: 84 YR
• Patient Sex: Female