BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2081536 · Received April 19, 2011

    Report

    Report Number
    3007566237-2011-02905
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Report Date
    March 21, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS GOING TO UNDERGO A LEAD REVISION TO REVISE THE POSITION OF THE LEAD WHICH HAD MOVED OFF TO THE RIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MEDTRONIC NEUROMODULATION 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 LEAD: MODEL 39565, LOT# UNK| IMPLANTED:| EXPLANTED: