BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 1738129 · Received June 24, 2010

    Report

    Report Number
    MW5016500
    Event Type
    Injury
    Date Received
    June 24, 2010
    Date of Event
    December 16, 2009
    Report Date
    June 5, 2010
    Manufacturer
    MEDTRONIC
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WITH SPASTIC QUADRAPLEGIA AND MENTAL RETARDATION ADMITTED TO THE PICU ON (B)(6) 2009, FOR ACUTE RENAL INSUFFICIENCY AND INCREASED WORK OF BREATHING. PT WAS INTUBATED AND MECHANICALLY VENTILATED FOR FOUR WEEKS, WITH SEVERAL FAILED EXTUBATION ATTEMPTS SECONDARY TO HYPERCARBIA AND INCREASED TONE. HER INCREASED TONE WAS ATTRIBUTED TO BACLOFEN PUMP FAILURE AND INABILITY TO DELIVER BACLOFEN ACCURATELY VIA THE PUMP. PER THE PHYSICIAN'S NOTES, THE PT HAD PROBLEMS FOR SEVERAL YEARS PRIOR TO THIS ADMISSION WITH ALTERNATING TOO MUCH VERSUS TOO LITTLE PUMP DELIVERY OF BACLOFEN. IN ADDITION, THE RESIDUAL BACLOFEN VOLUME UPON REFILLS NEVER SEEMED TO CORRESPOND TO THE PROJECTED RESIDUAL VOLUME BASED UPON HER RATE OF FLOW. IN ORDER TO SUCCESSFULLY EXTUBATE THE PT THE DECISION WAS MADE TO REPLACE THE PUMP. THIS SURGERY OCCURRED (B)(6) 2009. AFTER THE PUMP WAS REPLACED, IMPROVEMENTS IN HER HYPERTONICITY AND HYPERCARBIA WERE NOTED BEGINNING (B)(6) 2009. ON (B)(6) 2009, THE PT WAS EXTUBATED AND MAINTAINED ON BIPAP. SHE WAS DISCHARGED TO HOME ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC SYNCHROMED II BACLOFEN PUMP LKK MEDTRONIC 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization