MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE

Model Number LSP112V

Device Problems Signal Artifact/Noise (1036); Failure to Interrogate (1332); Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Low impedance (2285); Inappropriate or Unexpected Reset (2959)

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

Event Date 12/16/2022

Event Type  malfunction  

Event Description

It was reported the patient presented for a leadless pacemaker implant procedure.During implant, it was observed the ventricular leadless pacemaker had low pacing impedance.At final placement, a radiofrequency (rf) generator was turned on for an eventual ablation procedure and noise saturation spiked, causing loss of telemetry, no marker channels, and no green lights.The rf generator and external defibrillator were deactivated, leading to re-established telemetry that indicated the device had reset.Programming changes were performed and the device was successfully implanted with the successive ablation complete.All electrical values were normal except the device still exhibited low pacing impedance.The device was checked the following day on(b)(6)2022 and displayed an increased impedance, but with no battery longevity estimate.The patient was stable.

Manufacturer Narrative

The reported event of impedance anomaly was confirmed.Based on the information provided, the root cause of the event could not be determined.

• Brand Name: AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE
• Type of Device: LEADLESS PACEMAKER
• 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: 16100156
• MDR Text Key: 307301436
• Report Number: 2017865-2023-00303
• Device Sequence Number: 1
• Product Code: PNJ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P150035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2023
• Device Model Number: LSP112V
• Device Catalogue Number: LSP112V
• Device Lot Number: S000087699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2022
• 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
• Treatment: AVEIR DELIVERY CATHETER; EXTERNAL DEFIBRILLATOR; RF GENERATOR
• Patient Age: 97 YR
• Patient Sex: Female