BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3190341 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10877
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT DEVELOPED KLEBSIELLA BACTEREMIA AND A CEREBROSPINAL FLUID (CSF) INFECTION, TWO WEEKS AFTER THE PUMP WAS IMPLANTED. IT WAS SAID, THE CSF WAS ASPIRATED FROM THE CAP ON (B)(6) 2013 AND THE INFECTION WAS DETERMINED THE FOLLOWING DAY. THE CATHETER AND PUMP REMAIN IMPLANTED AT THE TIME OF REPORT. THE MANAGING PHYSICIAN AND SURGEON ARE WORKING WITH INFECTIONS DISEASE TO DETERMINE THE BEST PLAN OF ACTION. THE PATIENT HAD A FEVER. THE PUMP WAS DELIVERING LIORESAL. IT WAS LATER REPORTED, THE PATIENT HAD THE CATHETER REMOVED THE WEEK PRIOR TO (B)(6) 2013, AND THE PUMP REMAINED IMPLANTED. REPORTEDLY, THE HEALTH CARE TEAM PLANNED TO RE-IMPLANT A CATHETER AT ANOTHER DATE, AFTER THE INFECTION WAS RESOLVED. IT WAS LATER REPORTED THAT THE PATIENT WAS DIAGNOSED WITH MENINGITIS, AND THE EXACT DATE OF CATHETER REMOVAL WAS NOT KNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    PER THIS REPORTER, THE CATHETER WAS INITIALLY EXPLANTED AND THEN THE PUMP WAS LATER EXPLANTED 2-3 WEEKS AFTER IMPLANT DUE TO THE INFECTION. THE PATIENT WAS IMPLANTED WITH THE NEW SYSTEM ON (B)(6) 2015.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT AS FAR AS THE REPORTER KNEW THE INFECTION WAS SYSTEMIC AND NOT LIMITED TO ANY ONE AREA. IT WAS ALSO NOTED THAT THE HEALTHCARE PROVIDER HAD ¿JUST¿ MOVED AND WAS SETTING UP. THE REPORTER NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289787 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00026 YR Hospitalization| R