BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENESIS

    MDR report key: 3032743 · Received March 13, 2013

    Report

    Report Number
    1627487-2013-05351
    Event Type
    Other
    Date Received
    March 13, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    IT WAS REPORTED THE PT RECEIVED A LOW BATTERY WARNING. AN SJM REP MET WITH THE PT AND CLEARED THE LOW BATTERY FLAG. LONGEVITY CALCULATIONS REVEALED POSSIBLE BATTERY PASSIVATION. THE PT WILL F/U ON A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106621 GENESIS SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3643 3254447

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention SCS LEADS: MODEL 3166 (2)| IMPLANT: