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

Model Number 5826

Device Problems Pacemaker Found in Back-Up Mode (1440); No Pacing (3268)

Patient Problem Arrhythmia (1721)

Event Date 10/24/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced cardiac arrest during the pacemaker replacement.The pacemaker exhibited no pacing and was found to be in the back-up mode.The pacemaker was explanted.Patient was stable.

Manufacturer Narrative

Reported event of no low voltage output was not confirmed.Reported event of device found in backup vvi mode was confirmed.Device was received operating in backup mode.Analysis of device image indicated device went into backup mode during explant procedure, which was consistent with exposure to electrocautery.After the device was restored from backup mode, the device was found to be above elective replacement indicator (eri).Further analysis performed found no anomaly.Longevity assessment was performed, and implant duration has exceeded total projected longevity indicating normal battery depletion.

• Brand Name: ZEPHYR XL DR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• 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: 15786008
• MDR Text Key: 303554038
• Report Number: 2017865-2022-45178
• 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,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2013
• Device Model Number: 5826
• Device Catalogue Number: 5826
• Device Lot Number: 3709294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2012
• 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 Outcome(s): Other