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

Model Number 5826

Device Problems Failure to Capture (1081); Pacemaker Found in Back-Up Mode (1440)

Patient Problems Syncope (1610); Arrhythmia (1721); Syncope/Fainting (4411)

Event Date 12/18/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported the dependent patient was brought to the emergency room after being found unresponsive and was being externally paced.Upon interrogation, it was observed the pacemaker was in backup vvi.An emergency generator replacement surgery was completed to replace the pacemaker.The patient was unresponsive going into procedure and their condition post procedure was unknown.

Manufacturer Narrative

Analysis was completed.Backup operation was traced to normal battery depletion.No further issues observed.

• 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
• MDR Report Key: 11132103
• MDR Text Key: 225536365
• Report Number: 2017865-2021-00848
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734501620
• UDI-Public: 05414734501620
• Combination Product (y/n): N
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2010
• Device Model Number: 5826
• Device Catalogue Number: 5826
• Device Lot Number: 2748436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 03/10/2021
• Supplement Dates FDA Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 76 YR