BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 2881444 · Received December 17, 2012

    Report

    Report Number
    1627487-2012-11841
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    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 PHYSICIAN IMPLANTED A NEW LEAD. IT WAS UNDETERMINED WHETHER THE LEAD REPLACED AN EXISTING LEAD OR WHETHER THE LEAD WAS AN ADDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3716| IMPLANT DATE:| SCS EXTENSION: MODEL 3383