BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTA RECHARGEABLE IPG

    MDR report key: 19489285 · Received June 7, 2024

    Report

    Report Number
    1627487-2024-09221
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    May 17, 2024
    Report Date
    April 17, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MHY
    UDI-DI
    05415067047663
    PMA / PMN Number
    P140009
    Removal / Correction Number
    1627487-05/30/24-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION A3A- GENDER. CORRECTION- DATE OF BIRTH. CORRECTION G3- PMA/510(K) #- P140009. CORRECTION H6- MEDICAL DEVICE PROBLEM CODE- 4032 - UNINTENDED APPLICATION PROGRAM SHUT DOWN. CORRECTION H7- REMEDIAL ACTION INITIATED, CHECK TYPE- RECALL, NOTIFICATION, AND OTHER SELECTED; OTHER REMEDIAL ACTION- CORRECTION. THE EVENT OF LIBERTA THERAPY TURNING OFF WAS REPORTED TO ABBOTT. THE LIBERTA FIRMWARE VERSION CHECK SOFTWARE CONFIRMED THE CURRENT NORDIC VERSION OF THE IPG IS 1.1.1.29 AND THE CURRENT MSP VERSION IS 1.1.1.67 INDICATING THE FW UPDATE WAS COMPLETED SUCCESSFULLY. SINCE THE UPDATE HAS BEEN COMPLETED, THE PATIENT'S THERAPY WILL NO LONGER TURN OFF UNEXPECTEDLY. THE ISSUE HAS BEEN RESOLVED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION; HOWEVER, DATA LOGS WERE RECEIVED. BASED ON THE INFORMATION RECEIVED, A SINGLE DEFINITIVE ROOT CAUSE FOR THE ISSUE ENCOUNTERED WAS UNABLE TO BE CONCLUSIVELY DETERMINED. AS A RESULT OF THIS FINDING, ABBOTT IS PERFORMING FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS INCLUDED IN THE NEUROMODULATION IMPLANTABLE PULSE GENERATOR (IPG) STIMULATION UNEXPECTEDLY TURNING OFF ADVISORY NOTICE ISSUED BY ABBOTT ON 16 MAY 2024. FSCA NUMBER IS PENDING.

    Additional Manufacturer Narrative · 0

    THE FSCA NUMBER IS INCLUDED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    A THERAPY OFF EVENT WAS REPORTED TO ABBOTT. THE THERAPY OFF ISSUE WAS CONFIRMED VIA SOFTWARE CHECK. INSUFFICIENT DATA LOGS WERE PROVIDED, HOWEVER THE IPG SOFTWARE WAS UPDATED TO RESOLVE THE ISSUE. ACTIONS HAVE BEEN TAKEN TO PREVENT REOCCURRENCE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE ISSUE OF UNEXPECTED IPG SHUTDOWN WAS RESOLVED FOLLOWING IMPLEMENTATION OF A SOFTWARE UPDATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S IPG SHUTDOWN UNEXPECTEDLY. AS A RESULT, TROUBLESHOOTING WAS PERFORMED WHICH RESOLVED THIS ISSUE. BASED ON INFORMATION OBTAINED THE DEVICE IS INCLUDED IN THE NEUROMODULATION IMPLANTABLE PULSE GENERATOR (IPG) STIMULATION UNEXPECTEDLY TURNING OFF ADVISORY NOTICE ISSUED BY ABBOTT ON 16 MAY 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1722844 LIBERTA RECHARGEABLE IPG DBS IPG MHY ABBOTT MEDICAL 62400 10211564 05415067047663
    2318203 LIBERTA RECHARGEABLE IPG DBS IPG MHY ABBOTT MEDICAL 62400 10211564 05415067047663

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female DBS BURR HOLE CAP (2)| DBS EXTENSION (2)| DBS LEAD (2)