BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC

    MDR report key: 3231513 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-10227
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    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

    IT WAS REPORTED, THE PHYSICIAN IS UNABLE TO PROGRAM THE PATIENT'S IPG (ITALY). ADDITIONALLY, WHEN TRYING TO ESTABLISH COMMUNICATION WITH THE IPG, AN ERROR MESSAGE INDICATING THE IPG BATTERY VOLTAGE IS TOO LOW TO PROVIDE STIMULATION IS DISPLAYED. PREMATURE BATTERY DEPLETION IS SUSPECTED. FURTHER INVESTIGATION REVEALED THAT SURGICAL INTERVENTION WILL BE UNDERTAKEN AT A LATER DATE TO RESOLVE THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324734 EONC SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3588 3071743

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other