MAUDE Adverse Event Report: ABBOTT ZEPHYR XL DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 5826

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 02/28/2024

Event Type  malfunction  

Event Description

It was reported that during a device replacement procedure due to normal battery depletion, the set screw of the device was difficult to loosen resulting in the silicone detaching from the header.The device was explanted and replaced.The patient was in stable condition.

Manufacturer Narrative

The reported event of the atrial setscrew was difficult to get out was not confirmed.Analysis revealed the atrial setscrew was normal with no damage or stripping.The septum was removed by the physician.Then the setscrew was untightened and removed by the physician in the hospital in the field.This indicates no problem with the setscrew.The setscrews were tested in the lab and found to tighten and loosen normally and found to have no damage or stripping.No anomalies were found.

• Brand Name: ZEPHYR XL DR
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18832721
• MDR Text Key: 336848815
• Report Number: 2017865-2024-34027
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734501620
• UDI-Public: 05414734501620
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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: 08/31/2016
• Device Model Number: 5826
• Device Lot Number: A000002020
• 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: Not provided
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2015
• 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