BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2955553 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02523
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    January 15, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD DEEP AND SUPERFICIAL CELLULITIS AT THE CATHETER IMPLANT SITE; ON THE SKIN/SCAR WHERE THE INTRATHECAL CATHETER HAD BEEN IMPLANTED. THE CATHETER WAS EXPLANTED AND THE PATIENT WAS HOSPITALIZED. IT WAS REPORTED THE PATIENT WAS STILL IN THE HOSPITAL ON THE DAY OF REPORT. IT WAS NOTED THE PATIENT HAD A HISTORY OF MULTIPLE LUMBAR SPINE SURGERIES AND OSTEOMYELITIS WHICH AFFECTED THE LUMBAR SPINE. IT WAS LATER REPORTED THE CELLULITIS WAS DEVELOPED AT THE CATHETER IMPLANT SITE AND DEEPER AT THE SPINE. IT WAS REPORTED THIS WAS NOT RELATED TO THE PUMP BUT THE PUMP WAS EXPLANTED AND THE PATIENT RECEIVED TREATMENT. THE DEVICE SYSTEM HAD BEEN USED TO DELIVER FENTANYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58763 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R