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

Model Number LSP201A

Device Problems Failure to Capture (1081); Difficult or Delayed Positioning (1157); Over-Sensing (1438); Low impedance (2285); Device Dislodged or Dislocated (2923)

Patient Problem Embolism/Embolus (4438)

Event Type  Injury  

Event Description

It was reported that the patient presented for leadless pacemaker (lp) implant.During the procedure, it was noted that there was difficulty in positioning and fixing the lp.The pacing impedance was noted to decrease.Post-implant, capture failure and far r-wave over-sensing was noted.X-ray confirmed the lp had dislodged.The lp was explanted and replaced.The patient was stable.

Manufacturer Narrative

The reported event of dislodgement, failure to capture, difficult or delayed positioning, low impedance, and over sensing were not confirmed.Final analysis found no anomalies on the helix and the helix length no anomalies contributing to reported event of impedance, capture, or sensing problem.No issues were detected.

• Brand Name: AVEIR¿ LEADLESS PACEMAKER, RIGHT ATRIUM
• 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: 18872271
• MDR Text Key: 337290305
• Report Number: 2017865-2024-34502
• Device Sequence Number: 1
• Product Code: PNJ
• UDI-Device Identifier: 05415067040701
• UDI-Public: 05415067040701
• 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: 03/25/2024

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: LSP201A
• Device Lot Number: S000091904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/10/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2023
• 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
• Treatment: AVEIR RIGHT VENTRICULAR LEADLESS PACEMAKER
• Patient Outcome(s): Required Intervention
• Patient Sex: Female