BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 1963674 · Received December 21, 2010

    Report

    Report Number
    1627487-2010-03821
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT RECEIVED HER SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT BOTH THE RECHARGE BURDEN AND RECHARGE TIME FOR HER IPG HAS INCREASED. IT WAS RECOMMENDED THAT THE PATIENT MONITOR THE IPG CHARGE LEVEL VIA THE PROGRAMMER TO ENSURE THAT ALL COMPONENTS OF HER SCS SYSTEM ARE FUNCTIONING PROPERLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS BEING SUBMITTED AS A PRECAUTIONARY MEASURE AS SIMILARLY REPORTED EVENTS HAVE LED TO THE EXPLANT OF THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3788 2887102

    Patients

    Seq Age Sex Outcome Treatment
    1