BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 2930337 · Received January 21, 2013

    Report

    Report Number
    1627487-2013-00060
    Event Type
    Injury
    Date Received
    January 21, 2013
    Date of Event
    March 9, 2012
    Report Date
    January 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
    AS
    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 ((B)(6)) IPG WAS NO LONGER FUNCTIONING. AS SUCH, THE DEVICE WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RECAPTURED FOR THE PATIENT FOLLOWING THE PROCEDURE. SPECIFICS REGARDING THE SUSPECT DEVICE ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28715 UNK SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention