BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 3142732 · Received June 3, 2013

    Report

    Report Number
    3007566237-2013-01833
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL:UNK, SERIAL/LOT#:UNK, (B)(4).

    Description of Event or Problem · 1

    KRETZSCHMAR, M., GRO, W., SEIDEL, J., PETERS, F., REMANE, D. ABSTRACTS FROM THE ANNUAL MEETING OF THE GERMAN SOCIETY OF NEUROMODULATION (DGNM) JOINT MEETING WITH THE NEUROMODULATION SOCIETY OF THE UNITED KINGDOM AND IRELAND (NSUKI). 23-24 NOVEMBER 2012, BERLIN, GERMANY. INTRATHECAL HYDROMORPHON AND PREGNANCY: CASE REPORT AND IMPLICATIONS FOR CLINICAL CARE. NEUROMODULATION: TECHNOLOGY AT THE NEURAL INTERFACE. 2013;16(2):E5. SUMMARY/REPORTED EVENT: THE PATIENT WAS A 41-YEAR-OLD WITH A HISTORY OF FAILED BACK SURGERY SYNDROME WHOSE INTRACTABLE PAIN HAS BEEN MANAGED WITH INTRATHECAL HYDROMORPHONE 1.2 MG PER DAY VIA AN IMPLANTED PUMP FOR 1.5 YEARS. THIS WAS THE THIRD PREGNANCY, THE PATIENT ALREADY HAS TWO CHILDREN (9 AND 18 YEARS). THE PREGNANCY WAS UNEVENTFUL UP TO THE 23RD WEEK WITHOUT ANY PROBLEMS. AT THAT STAGE, SHE DEVELOPED SHORT LIVED HYPERTENSIVE EPISODES FOR A FEW DAYS WHICH WERE WELL CONTROLLED BY ANTIHYPERTENSIVE DRUGS. FROM THE 30TH WEEK BACK PAIN INCREASED IN THE AREA OF PREVIOUS BACK SURGERY. AT 35 + 3RD A PRETERM NORMAL-TO-DATES INFANT ((B)(6)) WAS DELIVERED BY CAESAREAN SECTION (LSCS). 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
    244172 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention