BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE INFUSION PUMP

    MDR report key: 6670099 · Received June 27, 2017

    Report

    Report Number
    3007566237-2017-02552
    Event Type
    Injury
    Date Received
    June 27, 2017
    Date of Event
    March 1, 2014
    Report Date
    June 27, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    WELPE P. [SPINAL CATHETER-ASSOCIATED CEREBROSPINAL FLUID LEAK]. SCHMERZ (BERLIN, GERMANY). 2016. DOI: 10.1007/S00482-016-0117-6 SUMMARY: IN OUR OUTPATIENT PAIN CLINIC AT THE CANTONAL HOSPITAL OF MÜNSTERLINGEN IN SWITZERLAND, WE ARE TREATING A (B)(6) PATIENT WHO, DESPITE UNDERGOING SEVERAL PROCEDURES ON THE LUMBAR SPINE, SUFFERS FROM PERSISTENT BACK AND LEG PAIN AS PART OF FAILED BACK SURGERY SYNDROME. SEVEN YEARS AGO, SHE WAS THEREFORE GIVEN AN INTRATHECAL PAIN PUMP AT AN EXTERNAL HOSPITAL. REPORTED EVENTS: AS THERE WERE CONSIDERABLE DISCREPANCIES REGARDING THE CALCULATED AND EFFECTIVE RESIDUAL VOLUME OF THE PUMP FILLING LEVEL, THE GAS PRESSURE PUMP WAS REPLACED IN SPRING 2014 DUE TO INCREASING MALFUNCTION. SEE ATTACHED LITERATURE ARTICLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451741 IMPLANTABLE INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention