BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 2893544 · Received January 2, 2013

    Report

    Report Number
    3007566237-2013-00008
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    December 5, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT REPORTED THAT SHE HAD "THREE BACLOFEN PUMPS" AND THEY WERE TAKEN OUT ON DIFFERENT OCCASIONS DUE TO "SKIN BREAKDOWN" (THE FIRST PUMP REPLACEMENT HAS BEEN REPORTED IN MFR REPORT # 6000030-2013-00001 AND THE SECOND PUMP EXPLANT HAS BEEN REPORTED IN MFR REPORT # 3007566237-2013-00007). IT WAS ADDED THAT PATIENT WAS A "SMALL PERSON WITH A SHORT TORSO, SKIN STARTED TO BREAK DOWN IT WAS PART OF A VISCOUS CIRCLE." ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER NOTED THAT AFTER HAVING GONE THROUGH THE WHOLE 10 YEARS OF RECORDS FOR THIS PATIENT, THE PATIENT ONLY HAD TWO PUMPS PLACED; AND THE TYPE OF BACLOFEN ADMINISTERED VIA THE PATIENT'S PUMP WAS COMPOUNDED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197 UNKNOWN PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNWON