BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 3161487 · Received June 5, 2013

    Report

    Report Number
    1627487-2013-10186
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    March 13, 2013
    Report Date
    May 17, 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
    SP
    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'S LEAD FAILED AND THE SCS SYSTEM WAS SUBSEQUENTLY EXPLANTED (B)(6). PLEASE NOTE: ADDITIONAL INFO HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFO WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249224 UNK SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention