BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 6093633 · Received November 10, 2016

    Report

    Report Number
    3007566237-2016-04021
    Event Type
    Injury
    Date Received
    November 10, 2016
    Date of Event
    August 13, 2016
    Report Date
    November 10, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PT AGE: PLEASE NOTE THAT THIS AGE IS THE MEDIAN AGE OF THE PATIENTS REPORTED IN THE ARTICLE, AS THE ACTUAL AGE OF PATIENTS INVOLVED WAS NOT PROVIDED. PT GENDER: PLEASE NOTE THAT THIS IS THE GENDER OF THE MAJORITY OF PATIENTS REPORTED IN THE ARTICLE AS THE ACTUAL GENDERS OF PATIENTS INVOLVED WAS NOT PROVIDED. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE : IMPLANTABLE NEUROSTIMULATOR. 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.

    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 DEEP BRAIN STIMULATION (DBS) 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). HOWEVER, THE PATIENT EXPERIENCED A RECURRENCE OF THE INFECTION AT 229 DAYS AFTER COMPLETING SAT. THE PATIENT REQUIRED REMOVAL OF THE DEVICE. THE PATIENT WAS CURED FOLLOWING REMOVAL OF THE DEVICE. MICROBIOLOGICAL CULTURES WERE TAKEN; HOWEVER, THE RESULTS WERE UNCLEAR AS THE ARTICLE DID NOT SPECIFY THE RESULTS FOR THIS PATIENT; 2 PATIENTS WITH DEEP BRAIN STIMULATION (DBS) EXPERIENCED A DEVICE INFECTION. THE PATIENTS RECEIVED INTRAVENOUS ANTIMICROBIAL TREATMENT FOR THE NEUROSURGICAL INFECTION (NSI), WHICH WAS CAUSED BY MICRO-ORGANISMS SUSCEPTIBLE TO LINEZOLID; THE PATIENTS ONLY REQUIRED HOSPITALIZATION TO RECEIVE INTRAVENOUS ANTIMICROBIAL TREATMENT AND WERE DISCHARGED WITH ORAL LINEZOLID AS SEQUENTIAL ANTIMICROBIAL TREATMENT (SAT). THESE PATIENTS DID NOT REQUIRE REMOVAL OF THE DEVICE; THE PATIENTS SHOWED NO CLINICAL OR LABORATORY SIGNS OF INFECTION DURING FOLLOW-UP AND WERE ABLE TO KEEP THEIR DEVICES. MICROBIOLOGICAL CULTURES WERE TAKEN; HOWEVER, THE RESULTS WERE UNCLEAR AS THE ARTICLE DID NOT SPECIFY THE RESULTS FOR THESE PATIENTS. THERE WAS NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744507 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other| R