BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1081351 · Received July 24, 2008

    Report

    Report Number
    3004209178-2008-04340
    Event Type
    Injury
    Date Received
    July 24, 2008
    Report Date
    June 25, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD THEIR DBS LEADS REPOSITIONED TWICE DUE TO DISCOMFORT AND BEING TOO CLOSE TO THE SURFACE OF THE SKIN. IT WAS FURTHER REPORTED "IF THE INS WAS CLOSER TO THE LEADS, IT WOULD PREVENT HAVING LEADS DOWN THE NECK AND REDUCE THE CHANCE OF LEAD MIGRATION AND/OR BREAKS AND INCREASE MOBILITY FOR THE PT". THE DATE OF THE SECOND REPORTED 'REVISION" WAS NOT REPORTED. SEE MFR REPORT # 3004209178-2008-4337. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| EXTENSION MODEL 7482 LOT# NHU123143V| IMPLANTED| LEAD MODEL 3389 LOT# V003144| LOT# NFW134135H| IMPLANTED| IMPLANTED| IMPLANTABLE NEUROSTIMULATOR MODEL 7426| EXPLANTED| EXPLANTED| IMPLANTED| EXTENSION MODEL 7482 LOT# NHU131383V| EXPLANTED| LEAD MODEL 3389 LOT# V003144| EXPLANTED| IMPLANTED