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

Model Number LSP112V

Device Problems Failure to Capture (1081); High impedance (1291); Therapy Delivered to Incorrect Body Area (1508); Device Dislodged or Dislocated (2923)

Patient Problems Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Discomfort (2330); Cardiac Perforation (2513); Pericardial Effusion (3271); Embolism/Embolus (4438)

Event Date 02/13/2024

Event Type  Injury  

Event Description

Related manufacturer reference number: (b)(4).It was reported the patient presented for implant procedure.During surgery, the leadless pacemaker (lp) was fixated and had no capture, high pacing impedance and little current of injury.The lp was redocked with the delivery catheter and unfixed.The patient's blood pressure began to drop.Pericardiocentesis was performed and plasma and blood were given to the patient.The lp was implanted and the patient was sent to have the perforation repaired while exhibiting tachycardia.After surgery, the patient exhibited bradycardia and diaphragm stimulation.Fluoroscopy showed the lp had dislodged to the left femoral vein.The lp was explanted and replaced.Post-procedure, the patient was in stable condition.

Manufacturer Narrative

A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.The reported events of failure to capture, high pacing impedance, diaphragm stimulation and post op dislodgement could not be confirmed.The leadless pacemaker was returned for analysis.No anomaly was noted, the device passed all tests.Further analysis was performed, including output and impedance tests, and the device exhibited normal device characteristics without any anomalies.Longevity assessment was performed, and device was in the normal range of operation with appropriate remaining longevity.

• 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: 18822667
• MDR Text Key: 336732338
• Report Number: 2017865-2024-33910
• 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: 03/14/2024

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 Model Number: LSP112V
• Device Lot Number: S000093293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2024
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 100 KG