BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE INFUSION PUMP

    MDR report key: 6095672 · Received November 11, 2016

    Report

    Report Number
    3007566237-2016-04040
    Event Type
    Injury
    Date Received
    November 11, 2016
    Date of Event
    August 13, 2016
    Report Date
    November 11, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MARTIN-GANDUL, C., MAYORGA-BUIZA, M.J., CASTILLO-OJEDA, E., GÓMEZ-GÓMEZ, M.J., RIVERO-GARVÍA, M., GIL-NAVARRO, M.V., MÁRQUEZ-RIVAS, F.J., JIMÉNEZ-MEJÍAS, M.E. SEQUENTIAL ANTIMICROBIAL TREATMENT WITH LINEZOLID FOR NEUROSURGICAL INFECTIONS: EFFICACY, SAFETY AND COST STUDY. ACTA NEUROCHIRURGICA. 2016. 158(10):1837-1843. DOI: 10.1007/S00701-016-2915-0. SUMMARY: EVIDENCE FOR THE EFFECTIVENESS OF LINEZOLID IN NEUROSURGICAL INFECTIONS (NSIS) IS GROWING. THE COMFORTABLE ORAL DOSAGE AND TOLERANCE OF LINEZOLID OPENS THE POSSIBILITY FOR SEQUENTIAL ANTIMICROBIAL TREATMENT (SAT) IN STABLE PATIENTS AFTER A PERIOD OF INTRAVENOUS TREATMENT. REPORTED EVENTS: 1 PATIENT WITH A BACLOFEN INFUSION PUMP EXPERIENCED A DEVICE INFECTION. THE PATIENT RECEIVED INTRAVENOUS ANTIMICROBIAL TREATMENT FOR THE NEUROSURGICAL INFECTION (NSI), WHICH WAS CAUSED BY MICRO-ORGANISMS SUSCEPTIBLE TO LINEZOLID; THE PATIENT ONLY REQUIRED HOSPITALIZATION TO RECEIVE INTRAVENOUS ANTIMICROBIAL TREATMENT AND WAS DISCHARGED WITH ORAL LINEZOLID AS SEQUENTIAL ANTIMICROBIAL TREATMENT (SAT). THIS PATIENT DID NOT REQUIRE REMOVAL OF THE DEVICE; THE PATIENT SHOWED NO CLINICAL OR LABORATORY SIGNS OF INFECTION DURING FOLLOW-UP AND WAS ABLE TO KEEP THEIR DEVICES. MICROBIOLOGICAL CULTURES WERE TAKEN; HOWEVER, THE RESULTS WERE UNCLEAR AS THE ARTICLE DID NOT SPECIFY THE RESULTS FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746891 IMPLANTABLE INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R