BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1052935 · Received May 27, 2008

    Report

    Report Number
    3004209178-2008-02821
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS UNABLE TO ADJUST STIMULATION THERAPY CONTROL; ONE PULSE GENERATOR IN THE BILATERAL SYSTEM WOULD NOT TURN ON. THE STATUS LIGHT ON THE PT PROGRAMMER HAD INDICATED STIMULATION THERAPY WAS TURNED OFF FOR THE DEVICE. BASIC TROUBLESHOOTING AND PT PROGRAMMER DEVICE FUNCTIONALITY WAS REVIEWED; THE PT WAS REDIRECTED TO REPORT SYMPTOMS TO THE HCP. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE PT. REFER TO MFR REPORT #3004209178200501120 AND #3004209178200501121.

    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 Other IMPLANTABLE NEURO STIMULATOR MODEL 7426| IMPLANTED| LEAD MODEL 3387| IMPLANTED| LEAD MODEL 3387| EXPLANTED| EXPLANTED| EXTENSION MODEL 7482| EXPLANTED| IMPLANTED| EXTENTION MODEL 7482 LOT# NHU063614V| EXPLANTED| IMPLANTED| IMPLANTED| LOT# NFW123545H| EXPLANTED