BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1924832 · Received December 7, 2010

    Report

    Report Number
    3007566237-2010-10298
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    September 7, 2010
    Report Date
    November 29, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REGULAR APPOINTMENT ON (B)(6) 2010, THE PT REPORTED PAIN IN THE AREA OF THE PUMP. A LIVID DISCOLORATION PAIN AND PRESSURE ON THE SKIN WAS NOTED WITH NO INFECTION OR DEHISCENCE. ON (B)(6) 2010, THE PT WAS HOSPITALIZED. THE INTERVENTION PROVIDED WAS UNK. THE PT RECOVERED AND THERAPY CONTINUED. IT WAS NOTED THAT THE PT DID NOT HAVE ENOUGH ADIPOSE TISSUE SO THE PUMP COULD SHIFT NEAR UNDER THE SKIN, AND EROSION COULD HAPPEN AGAIN. THE PUMP CONTAINED PRIALT 6MCG/DAY AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED LKK MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization