BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3954755 · Received July 24, 2014

    Report

    Report Number
    3004209178-2014-13470
    Event Type
    Injury
    Date Received
    July 24, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A COUPLE OF WEEKS PRIOR TO THE REPORT, THE PATIENT¿S GUITAR HIT HIS PUMP POCKET SITE AND THE AREA BECAME BRUISED AND SWOLLEN. AT THAT TIME, THE PATIENT WAS PUT IN A BINDER. A COUPLE OF DAYS PRIOR TO THE PATIENT¿S ADMISSION ON (B)(6) 2014, THE PATIENT¿S PARENTS NOTED SKIN BREAKDOWN AT THE PUMP POCKET SITE. ON (B)(6) 2014, IT WAS NOTED THAT THE PUMP POCKET WOUND HAD OPENED AND THE PUMP WAS EXPOSED THROUGH THE SKIN. THE SURGEON DECIDED TO EXPLANT THE DRUG DELIVERY SYSTEM. THERE WAS NO PRODUCT ISSUE. THE DEVICE SYSTEM WAS DELIVERING GABLOFEN. IT WAS LATER REPORTED THAT THE PATIENT WAS PLACED ON ORAL BACLOFEN. THE PATIENT WAS ALSO PUT ON VANCOMYCIN IV (INTRAVENOUS) FOR 2-3 WEEKS FOR INFECTION, ALTHOUGH PER REPORT, NO ORGANISM WAS FOUND FROM THE PUMP POCKET CULTURE THAT WAS TAKEN AT THE TIME OF EXPLANT. AS OF (B)(6) 2014, THE PATIENT HAD BEEN DISCHARGED TO HOME. THE PATIENT¿S WOUND WAS STILL IN THE HEALING PHASE AND THE PATIENT WOULD BE FOLLOWING UP ACCORDINGLY WITH NEUROSURGERY POST-EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433009 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00007 YR Hospitalization| R