BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3863552 · Received June 10, 2014

    Report

    Report Number
    3007566237-2014-01581
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    May 20, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND HAD THE MOST SEVERE PAIN ¿YOU COULD IMAGINE¿. IT WAS NOTED THAT THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WAS REMOVED 10 DAYS LATER AND HAD TO BE ON 2 DIFFERENT ANTIBIOTICS FOR 24 DAYS AND HAD LOST TIME FROM WORK. THE PATIENT STATED THAT THE TRIAL PHASE OF TESTING ¿WENT GREAT¿ AND ACHIEVED 80% PAIN RELIEF. UNABLE TO FOLLOW UP WITH THE CONTACT INFORMATION PROVIDED, HENCE NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338408 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Required Intervention