BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 4965742 · Received August 4, 2015

    Report

    Report Number
    3007566237-2015-02185
    Event Type
    Injury
    Date Received
    August 4, 2015
    Report Date
    July 18, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THESE EVENTS WITH ANY PREVIOUSLY REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ENISHI, T., INATSUGI, M., SATO, N., KATOH, S. REMOVAL AND REIMPLANTATION OF INTRATHECAL BACLOFEN SYSTEM PROVIDES SAFER TREATMENT FOR INFECTED CATHETER IN MENINGITIS: A CASE REPORT. PM AND R. 2014; 8 (2):S155 SUMMARY/REPORTED EVENT: AUTHOR DISCUSSION WAS ABOUT REMOVAL AND RE-IMPLANTATION OF THE INTRATHECAL BACLOFEN SYSTEM PROVIDING SAFER TREATMENT FOR AN INFECTED CATHETER IN MENINGITIS. A CASE REPORT WAS REGARDING A (B)(6) FEMALE PATIENT WHO PRESENTED WITH SPASTIC PARAPLEGIA DUE TO SYRINGOMYELIA. AFTER A SUCCESSFUL TRIAL BOLUS INJECTION OF BACLOFEN (UNKNOWN MANUFACTURER), THE INTRATHECAL BACLOFEN (ITB) SYSTEM WAS IMPLANTED. NINE MONTHS LATER, THE PATIENT FELT "HEADACHE AND FEVER UP IN HOSPITALIZATION." INTRAVENOUS ANTIBIOTIC TREATMENT WAS STARTED WITH CEFTRIAXONE SODIUM HYDRATE, IN COMBINATION WITH GENTACIN. REMOVAL OF THE ITB SYSTEM WAS PERFORMED. THE PUMP WAS NOT INFECTED BUT THE CATHETER WAS SURROUNDED BY INFECTED SCAR. THERE WAS NO ALLEGATION AGAINST THE IMPLANTED SYSTEM. FOUR MONTHS AFTER REMOVAL, ITB SYSTEM RE-IMPLANTATION WAS PERFORMED TO CONTROL SEVERE SPASTICITY. AUTHORS COMMENTED THAT REMOVAL AND RE-IMPLANTATION OF INTRATHECAL BACLOFEN SYSTEM PROVIDED A MORE SAFE TREATMENT FOR THE INFECTED CATHETER IN THE CASE OF MENINGITIS. THE EVENT DATE, DIAGNOSTIC TESTING, AND POTENTIAL CAUSES OF THE EVENTS WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508129 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR Hospitalization| R