BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3232409 · Received July 18, 2013

    Report

    Report Number
    3007566237-2013-02381
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    December 6, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION SULLILVAN LAKE
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387-40, LOT# UNKNOWN, IMPLANTED: UNKNOWN PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT USED TO GO 'OFF' QUITE A BIT AND THE WIRES PULLED. THE PATIENT HAD EXPERIENCING TINGLING ON THE LEFT SIDE OF HER BODY AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334634 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION SULLILVAN LAKE 7426

    Patients

    Seq Age Sex Outcome Treatment
    1