BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 5417622 · Received February 8, 2016

    Report

    Report Number
    3007566237-2016-00627
    Event Type
    Injury
    Date Received
    February 8, 2016
    Report Date
    January 15, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE WAS PREVIOUSLY REPORTED IN MANUFACTURER REPORT # 3007566237-2016-00221: ¿THE PATIENT¿S DIAGNOSIS INCLUDED BILATERAL SEVERE DYSKINETIC CEREBRAL PALSY BASED ON PREMATURITY AND STATUS AFTER INFANT RESPIRATORY DISTRESS SYNDROME (IRDS) GRADE 3 AND SEPSIS. THE PATIENT¿S MEDICAL HISTORY INCLUDED THE FIRST PUMP RECEIVED ON (B)(6) 2005. IN 2011, A DRAIN DISCONNECTION AND A NEW BACLOFEN PUMP AND RECONNECTION DRAIN ON (B)(6) 2011. THE NEW BACLOFEN PUMP WAS FOR A REGULAR REPLACEMENT OF THE PUMP, ALMOST END OF LIFE. THERE WERE NO KNOWN ALLERGIES.¿ ADDITIONAL INFORMATION WAS RECEIVED 2015-01-15 FROM A MANUFACTURER REPRESENTATIVE INDICATING THAT THE REVISION OF THE PUMP INVOLVED RE-CONNECTION OF THE CATHETER TO THE PUMP. THIS TOOK PLACE AFTER SUSPICION OF PUMP DYSFUNCTION. THE PATIENT NOTICED A FEW DAYS OF NO EFFECT OF THE BOLUS AND DYSTONIC MOVEMENTS CLEARLY INCREASED. X-RAY SHOWED A DISCONNECTION OF THE PUMP (ABDOMINAL SEGMENT TO THE PUMP). THIS WAS THE REASON FOR THE REVISION. THE DRUG USED AT THE TIME OF THE EVENT WAS NOT KNOWN, BUT IT WAS REPORTED THAT THE NEW PUMP CONTAINED BACLOFEN 2000 MICROGRAMS PER MILLILITER. THE DRUG DOSE, FREQUENCY, ROUTE, LOT NUMBER, THERAPY DATES, CONCOMITANT DRUGS WERE NOT REPORTED. THE DATE OF THE SUSPECTED MALFUNCTION WAS NOT REPORTED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74612 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_CATH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention