BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1083106 · Received July 24, 2008

    Report

    Report Number
    3004209178-2008-04318
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 26, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE PT HAD SEVERAL FALLS AND WAS NOT GETTING GOOD THERAPEUTIC RESULTS. IMPEDANCES WERE CHECKED AND FOUND TO BE >2000 OHMS ON ALL OR SOME OF THE UNIPOLAR PAIRS. THE STIMULATOR WAS REPROGRAMMED AND THE PT APPEARED TO BE GETTING BETTER RESULTS. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE. SEE MANUFACTURER'S REPORT #3004209178-2008-04317.

    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 71 YR Required Intervention IMPLANTED| IMPLANTED| EXPLANTED| STIMULATOR MODEL 7426| EXTENSION MODEL 7482 LOT#NHU009976V| EXPLANTED| LEAD MODEL 3389-40 LOT#J0309532V| IMPLANTED| EXPLANTED| EXTENSION MODEL 7482 LOT#NHU011051V| IMPLANTED| EXPLANTED| LEAD MODEL 3389-40 LOT#J0331941V| IMPLANTED| EXPLANTED