BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3202382 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-00894
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    April 2, 2012
    Report Date
    April 23, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP WAS CHANGED 3 WEEKS PRIOR TO THE DATE OF THIS REPORT AND PATIENT RECEIVED SEVEN TABLETS OF LIORESAL 10 MG FOR 2 DAYS. THE PUMP WAS PROGRAMMED AT THE SAME DOSE AS THE PREVIOUS PUMP. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED DUE TO MAJOR HYPOTONIA INCLUDING IMPOSSIBLE TO WALK AND LOSS OF THE SPHINCTERS (URINARY INCONTINENCE). THE DOSE OF THE DRUG WAS REDUCED BY HALF. THE PATIENT WAS DISCHARGED ON (B)(6) 2012. THE OUTCOME OF THE EVENT, LOSS OF CONTROL OF THE SPHINCTERS, WAS NOTED AS COMPLETE RECOVERY. THE CONDITIONS, HYPOTONIA AND IMPOSSIBILITY OF WALKING, REMAIN UNCHANGED. THE PHYSICIAN SUSPECTED THAT THE PATIENT WAS OVERDOSED FROM THE INTAKE OF LIORESAL TABLETS. THE PUMP WAS USED TO DELIVER BACLOFEN (LIORESAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301005 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Hospitalization| R