BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2655266 · Received July 13, 2012

    Report

    Report Number
    3004209178-2012-05599
    Event Type
    Malfunction
    Date Received
    July 13, 2012
    Report Date
    June 15, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: LEAD: MODEL 3389S-40, LOT# V043266, IMPLANTED: (B)(6) 2007, EXPLANTED: NA. EXTENSION: MODEL 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE IMPLANT OF A PACEMAKER THE MANUFACTURER REPRESENTATIVE HAD DIFFICULTY ESTABLISHING TELEMETRY WITH THE INS USING AN 8840 PHYSICIAN PROGRAMMER. THE PROGRAMMER REACTED VERY SLOWLY OR WAS UNABLE TO ESTABLISH TELEMETRY. THIS HAPPENED WITH A SECOND 8840 AS WELL. IT WAS NOTED THAT IT WAS POSSIBLE THAT ELECTROMAGNETIC INTERFERENCE IN THE ROOM WAS CAUSING A PROBLEM. ONCE THE PATIENT LEFT THE OPERATING ROOM THE 8840 RESPONDED NORMALLY. IT WAS REPORTED THAT THE PATIENT WAS DOING FINE. SEE MFR. REP. # 3004209178-2012-05598.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1