MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ZEPHYR XL DR; Pulse generator, permanent, implantable

Model Number 5826

Device Problems Incorrect Measurement (1383); Pacing Asynchronously (1441); No Pacing (3268)

Patient Problem Arrhythmia (1721)

Event Date 02/01/2023

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2023-24624 it was reported the patient presented to the hospital for device replacement.While hospitalized for the procedure, it was discovered the patient experienced cardiac arrest due to loss of low voltage output from the pacemaker.The pacemaker exhibited narrow atrio-ventricular intervals during ventricular impedance measurement testing and functional loss of capture.The right ventricular lead exhibited an impedance problem.The pacemaker and right ventricular lead were explanted and replaced.There were no patient consequences.

• 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: 17222587
• MDR Text Key: 318069550
• Report Number: 2017865-2023-24611
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734501620
• UDI-Public: 05414734501620
• 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
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2011
• Device Model Number: 5826
• Device Catalogue Number: 5826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2010
• 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: ISOFLEX
• Patient Outcome(s): Hospitalization; Required Intervention