BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3092720 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07298
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 5, 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 8709SC, SERIAL# (B)(4). PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S PUMP WAS EXPOSED THROUGH A SMALL OPENING AT THE INCISION SITE. THE INCISION REPORTEDLY DIDN'T HEAL WELL. TO "PREVENT FURTHER INFECTION", THE PUMP AND CATHETER WERE REMOVED AND A NEW SYSTEM WAS IMPLANTED ON THE OPPOSITE SIDE. IT WAS NOTED THE PUMP WAS "PROPHYLACTICALLY REPLACED." IT WAS LATER REPORTED THE PUMP WAS REPLACED PROPHYLACTICALLY TO PREVENT INFECTION. ORIGINALLY, THE PROCEDURE HAD BEEN SCHEDULED AS A POCKET REVISION ONLY. THE DEVICE SYSTEM WAS USED TO DELIVER HYDROMORPHONE. FOLLOWING THE REPLACEMENT, THE DOSE WAS LOWERED AND IT WAS UNKNOWN TO THE REPORTER HOW THE PATIENT HAD BEEN DOING SINCE. IT WAS NOTED THE DEVICE WAS SENT TO THE PATHOLOGY LAB. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193856 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention