BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS

    MDR report key: 2994008 · Received March 1, 2013

    Report

    Report Number
    1627487-2013-03297
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 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
    TX, US
    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 PATIENT'S SCS IPG WAS REPLACED DUE TO BATTERY DEPLETION. THE ISSUE HAS BEEN RESOLVED WITH THE REPLACEMENT SCS IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89299 GENESIS SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3608 3083978

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention SCS LEAD: MODEL 3244| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1192