BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 3201305 · Received June 26, 2013

    Report

    Report Number
    1627487-2013-10216
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT APPROVED FOR SALE IN THE USA, BUT IS SIMILAR TO A USA MARKETED/APPROVED DEVICE. 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

    THE PATIENT (B)(6) RECEIVED A DBS SYSTEM WHICH INCLUDED TWO LEADS. IT WAS REPORTED THAT IMPEDANCE ISSUES WERE ENCOUNTERED WHEN THE SYSTEM WAS TESTED. IT WAS NOTED, THE PATIENT DOES HAVE STIMULATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290537 UNK DBS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DBS IPG, MODEL 6644