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

Model Number LSP112V

Device Problems Failure to Capture (1081); Pacing Problem (1439)

Patient Problems Arrhythmia (1721); Dizziness (2194)

Event Date 03/08/2024

Event Type  malfunction  

Event Description

It was reported that during capture threshold testing, it was noted that the patient's leadless pacemaker was pacing at high output with no capture.Upon termination of the test, the patient's leadless pacemaker continued pacing at the inappropriate rate.The patient noted feeling dizzy due to arrhythmia.The test was re-run and upon termination, the correct rate was achieved and was able to successfully capture.The patient was stable.

• 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: 18987251
• MDR Text Key: 338719704
• Report Number: 2017865-2024-37030
• Device Sequence Number: 1
• Product Code: PNJ
• UDI-Device Identifier: 05415067034472
• UDI-Public: 05415067034472
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LSP112V
• Device Lot Number: S000093293
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 83 YR
• Patient Sex: Female