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

Model Number 5826

Device Problems Loose or Intermittent Connection (1371); Pacing Problem (1439)

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

Event Date 04/03/2024

Event Type  malfunction  

Event Description

It was reported that the patient presented for an implant procedure.During the procedure, it was noted that while attempting to fix the lead and the pacemaker, the set screw could not be tightened.Additionally, the pacing was not effective after connecting the pacemaker.The pacemaker was not used and a new pacemaker was implanted.The patient was recovering following the procedure.

Manufacturer Narrative

The reported event of inability to tighten the atrial setscrew to fix the lead was confirmed.Analysis revealed the physician was making incorrect wrench insertions into both a- and v-setscrews.Both setscrews were found completely stripped.Incorrect wrench insertions by the physicians caused the stripping of the setscrews.No device anomalies were found.The problems were user related.The reported event of inadequate low voltage output was not confirmed.Functional and electrical testing was normal when setscrews are properly tightened on the leads.

• 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: 19145381
• MDR Text Key: 340850539
• Report Number: 2017865-2024-39075
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734501620
• UDI-Public: (01)05414734501620(10)P000185852(17)250531
• 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: Physician
• Type of Report: Initial
• Report Date: 04/19/2024

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 Model Number: 5826
• Device Lot Number: P000185852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/09/2023
• 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