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

Model Number LSP201A

Device Problems Failure to Interrogate (1332); Stretched (1601); Capturing Problem (2891); Device Dislodged or Dislocated (2923)

Patient Problem Embolism/Embolus (4438)

Event Date 11/11/2023

Event Type  Injury  

Event Description

It was reported the patient underwent a leadless pacemaker (lp) implant.During implant, after fixation at a chosen location, the capture threshold increased but the lp remained implanted.The following day, the lp failed to be interrogated.A chest x-ray was completed to reveal the lp had dislodged and migrated to the opposite side of the heart.The lp was successfully retrieved, and it was noted to have a stretched helix.No replacement device was implanted.The patient was stable.

Manufacturer Narrative

Device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No anomaly was noted, the device passed all tests.The reported complaint of dislodgement and capturing problem were not confirmed.Visual inspection showed that the inner helix was clogged with blood/body tissue, and the outer helix was stretched out of specification.The helix elongation is consistent with having occurred during procedure.Telemetry, pacing and output features were analyzed, and the device exhibited normal electrical 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 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: 18248063
• MDR Text Key: 329500380
• Report Number: 2017865-2023-93646
• 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,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• 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: S000090695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White