BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3010619 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-03912
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    February 19, 2013
    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
    OTHER

    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) 2011. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT HAD SWELLING AND PAIN AT THE PUMP POCKET SITE. A SEROMA WAS REPORTED AND THE PATIENT WAS TO APPLY AN ABDOMINAL BINDER. IT WAS LATER REPORTED THAT THE PATIENT DEVELOPED A WOUND MEDIAL AND INFERIOR TO THE PUMP POCKET SITE. THE SKIN BECAME RED AND THE WOUND OPENED AND DRAINED. THE PATIENT WAS THEN ADMINISTERED ANTIBIOTICS AS AN INFECTION WAS SUSPECTED. ULTIMATELY, THE PUMP AND CATHETER WERE EXPLANTED ON (B)(6) 2013 AND WERE DISCARDED. CULTURES WERE TAKEN FROM THE POCKET SITE BEFORE AND AFTER THE INCISIONS WERE MADE. THE PATIENT WAS TO REMAIN ON ANTIBIOTICS AND REFERRED TO A WOUND CLINIC FOR EVALUATION. THIS DEVICE SYSTEM WAS USED TO DELIVER DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113351 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention