BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 2955540 · Received February 11, 2013

    Report

    Report Number
    3007566237-2013-00452
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    January 28, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: UNK, SERIAL/LOT#: UNK, IMPLANTED: UNK, EXPLANTED: UNK. IT WAS NOT POSSIBLE TO MATCH THESE EVENTS WITH ANY PREVIOUSLY REPORTED EVENTS. (B)(4).

    Description of Event or Problem · 1

    TSAI, N. T. MANAGEMENT OF INTRATHECAL BACLOFEN (ITB) PUMP DURING PREGNANCY. PM AND R. 2012;4(10):S346. SUMMARY: THREE PATIENTS WITH ITB PUMPS PLACED FOR SPASTICITY WERE FOLLOWED THROUGHOUT THEIR PREGNANCIES. ONE WAS FOLLOWED TWICE, TWO FOLLOWED ONCE. AS THE PATIENTS APPROACHED THEIR DUE DATES, THERE WAS MORE FREQUENT NEED OF RATE INCREASES, AS THEIR SPASTICITY INCREASED. IN ONE PATIENT WITH SEVERE BRAXTON-HICKS CONTRACTIONS, HER ITB PUMP WAS TURNED UP NEARLY 30% DURING THE LAST TRIMESTER. ALL OF THEM HAD EPIDURAL ANESTHESIA, WHICH WERE PERFORMED INFERIOR TO THEIR CATHETER INSERTION SITE. ALL THREE PATIENTS HAD C-SECTION DELIVERIES. ALL WERE TURNED DOWN WITHIN 5 DAYS OF DELIVERY BACK TO THE BASELINE RATE WITHOUT INCIDENT. REPORTED EVENT: AS THE TWO PATIENTS APPROACHED THEIR DUE DATES, THERE WAS MORE FREQUENT NEED OF RATE INCREASES, AS THEIR SPASTICITY INCREASED. THE PATIENTS UNDERWENT C-SECTION DELIVERIES. BOTH PUMPS WERE TURNED DOWN WITHIN 5 DAYS OF DELIVERY, BACK TO THE BASELINE RATE, WITHOUT INCIDENT. ADDITIONAL INFORMATION IS BEING REQUESTED AT THIS TIME; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59485 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention