BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 2370246 · Received December 13, 2011

    Report

    Report Number
    3007566237-2011-09228
    Event Type
    Injury
    Date Received
    December 13, 2011
    Date of Event
    October 1, 2010
    Report Date
    December 13, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: IMPLANTED: UNK EXPLANTED: UNK. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. THE PATIENT INFORMATION PROVIDED IN SECTION A IS THE AVERAGE/MEAN FOR ALL THE PATIENTS. AT THIS TIME NO ADDITIONAL INFORMATION WAS AVAILABLE BUT ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: AL KHUDHAIRI D, ALDIN AS, HAMDAN Y, ET AL. CONTINUAL INFUSION OF INTRATHECAL BACLOFEN (ITB): LONG-TERM EFFECT ON SPASTICITY. MIDDLE EAST JOURNAL OF ANESTHESIOLOGY. OCT 2010;20(6):851-855. SUMMARY: THE AUTHORS REPORTED ON 33 PATIENTS WHO HAD AN INTRATHECAL BACLOFEN PUMP IMPLANTED BETWEEN (B)(6) 2004 AND (B)(6) 2009 FOR SEVERE SPASTICITY. THERE WERE 9 FEMALES AND 24 MALES, AGES RANGING FROM 12 TO 57 YEARS DIAGNOSED WITH EITHER SPINAL INJURY OR BRAIN INSULT. DAILY INTRATHECAL BACLOFEN DOSE VARIED BETWEEN 50 AND 850 MCG/DAY. ALL 33 PATIENTS SHOWED SIGNIFICANT IMPROVEMENT. REPORTABLE EVENT: THE AUTHORS REPORTED THAT TWO PATIENTS EXPERIENCED AN INFECTION; ONE HAD THEIR PUMP EXPLANTED THREE MONTHS AFTER IMPLANTATION AND THE OTHER WAS EXPLANTED FOUR YEARS AFTER IMPLANTATION. ADDITIONALLY, THERE WAS ONE PATIENT WHO NEEDED SIGNIFICANTLY INCREASING DOSES OF BACLOFEN; THIS WAS DIAGNOSED AS CATHETER BREAKAGE AND THE CATHETER WAS REPLACED AFTER THREE YEARS OF IMPLANTATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00023 YR Required Intervention NEU_UNKNOWN_CATH LOT# UNK SERIAL# UNK