BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2840626 · Received November 20, 2012

    Report

    Report Number
    3007566237-2012-02788
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 30, 2012
    Report Date
    December 19, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE PUMP REVEALED NO ANOMALY.

    Additional Manufacturer Narrative · 1

    CATHETER 8711, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: UNKNOWN 8590-1, LOT# N206778, IMPLANTED: 2010 (B)(6), EXPLANTED: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE OUTCOME WAS ONGOING WITH NO FURTHER ACTION NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR (B)(6) WITH INFECTION. THE PATIENT EXPERIENCED FEVER, CHILLS, AND INCREASED LOW BACK PAIN SEVERAL DAYS PRIOR TO ADMISSION TO THE HOSPITAL AND ON ADMISSION ALTERED MENTAL STATUS, BLOOD SUGAR > 400, COMPLAINTS OF DECREASED SENSATION AND DECREASED ABILITY TO MOVE LOWER EXTREMITIES. THE PATIENT WAS (B)(6) FOR (B)(6), BACTEREMIA WITH 7/7 BOTTLES GROWING COAG AND ALSO A CT SCAN DONE (B)(6) 2012 SHOWED PSOAS ABSCESS AS WELL AS OSTEOMYELITIS DISKITIS AT L3-L4 AREA. THE LOCATION OF THE INFECTION WAS REPORTED TO BE AT THE L3-4 AREA OF THE LOWER BACK. IT WAS NOTED THAT EXTENSION OF INFECTION COULD NOT BE EXCLUDED AND ALSO SYSTEMIC BACTEREMIA. AN (B)(6) SCREEN WAS NEGATIVE ON (B)(6) 2012. THE PATIENT WAS TREATED WITH VANCOMYCIN AND IV LEVAQUIN FOR INFECTION, AND PRN DILAUDID FOR PAIN. THE SEVERITY WAS INDICATED AS SEVERE AND RESULTED IN IN-PATIENT OR PROLONGED HOSPITALIZATION. THE EVENT WAS INDICATED AS ON GOING. THE ENTIRE SYSTEM WAS EXPLANTED (B)(6) 2012. THE PUMP DELIVERED FENTANYL AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Hospitalization| R