BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 1962864 · Received January 13, 2011

    Report

    Report Number
    1627487-2011-01039
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 3. REFERENCE MANUFACTURER REPORTS: 1627487-2011-01040 AND 1627487-2011-01041. THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT THE PT LOST STIMULATION. THE PT PROGRAMMER DISPLAYED A "IPG BATTERY LOW" MESSAGE, BUT THE PT WAS UNABLE TO CHARGE HER IPG. THE PT STATED THAT SHE HAD NOT USED HER STIMULATOR FOR SEVERAL MONTHS. SHE REPORTED THAT HER STIMULATION PATTERN DID NOT MATCH HER PAIN PATTERN. FOLLOW UP ON THE PT FOUND THAT DURING A REPROGRAMMING SESSION, THE PROGRAMMER DISPLAYED A "STIM OFF" MESSAGE. AN ALTERNATE CHARGING SYSTEM WAS UNABLE TO CHARGE THE IPG. AN X-RAY SHOWED THAT THE PT'S DUAL LEADS HAD MIGRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3788 2770076

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention