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

Model Number 5826

Device Problems Pacemaker Found in Back-Up Mode (1440); Therapy Delivered to Incorrect Body Area (1508)

Patient Problem Discomfort (2330)

Event Date 09/20/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented in clinic for unrelated reason.Upon clinic visit, it was found that the pocket exhibited muscle stimulation and the pacemaker had gone into backup operation due to unknown cause.A reset was performed, and the pacemaker was restored.Patient condition was stable.

Manufacturer Narrative

Correction: g3 - date received by manufacturer in 2017865-2023-47079 submitted on 26 sep 2023 should have been "19 sep 2023" rather than "20 sep 2023.".

• 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: 17822385
• MDR Text Key: 324333411
• Report Number: 2017865-2023-47079
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734501620
• UDI-Public: 05414734501620
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

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: 12/31/2021
• Device Model Number: 5826
• Device Lot Number: P000105413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 09/27/2023
• Supplement Dates FDA Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2020
• 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