BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3983571 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-14014
    Event Type
    Injury
    Date Received
    August 6, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED PERIOPERATIVE ANTIBIOTICS HAD BEEN ADMINISTERED. RISK FACTORS THAT APPLIED TO THE STATUS OF THE PATIENT PRIOR TO DEVICE IMPLANT INCLUDED HAVING MULTIPLE SCLEROSIS AND A DEBILITATED STATUS. THE PATIENT DIDN¿T HAVE MENINGITIS. THE DATE OF THE LAST PUMP REFILL WAS NOT KNOWN. SYMPTOMS INCLUDED A FEVER, REDNESS, SWELLING, DRAINAGE, INCISIONAL WOUND OPENING AND POCKET EROSION. A CULTURE WAS OBTAINED OF THE DEVICE POCKET; THE TYPE OF ORGANISM CULTURED WAS STAPHYLOCOCCUS. IN TERMS OF TREATMENT, TOTAL DEVICE SYSTEM EXPLANT OCCURRED. OUTCOME WISE, THE INFECTION RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INFECTION AT THE PUMP POCKET IN THE RIGHT SIDE OF THE PATIENT¿S ABDOMEN. THEY WERE TREATING A SUPERFICIAL INFECTION AT THE PUMP SITE INCISION FOR ¿QUITE SOME TIME¿, BUT YESTERDAY THE PATIENT WAS ADMITTED TO THE HOSPITAL BECAUSE OF THE INFECTION. A HEALTH CARE PROFESSIONAL INQUIRED ABOUT DOSING CONSIDERATIONS AS THE PUMP WAS GOING TO BE REMOVED. THE PUMP WAS USED TO INFUSE LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461464 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00029 YR Hospitalization| R