BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SJM UNK

    MDR report key: 2080258 · Received April 7, 2011

    Report

    Report Number
    1627487-2011-02416
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 11, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 A DEVICE WAS EXPLANTED FROM A PATIENT ((B)(6)) AND APPEARED "RUSTY". ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE FACILITY REGARDING THE MODEL, LOT AND/OR SERIAL NUMBER OR IMPLANT/EXPLANT DATES FOR THE PRODUCT WERE UNSUCCESSFUL. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention