BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3170094 · Received June 14, 2013

    Report

    Report Number
    3004209178-2013-10375
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    May 21, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8782, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 8784, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. PRODUCT ID: 8782, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. PRODUCT ID: 8784, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER RECEIVED FROM THE HCP INDICATED THE CAUSE OF THE EVENT WAS EROSION THROUGH THE SKIN. THE ISSUE WAS AN INFECTED INCISION, NOT PUMP. THE PATIENT WAS RE-IMPLANTED (B)(6) 2013. THE PATIENT WAS NOTED AS DOING WELL SINCE IMPLANT/REPLACEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN EXPLANT ON (B)(6) 2013 OF HIS DEVICE SYSTEM DUE TO ¿SOME WOUND CLOSURE ISSUES AND TO PREVENT INFECTION. THE PATIENT HAD REPORTEDLY GONE TO THE EMERGENCY ROOM AND WAS TOLD ¿NO IT¿S OKAY¿ BUT THEN WENT TO THE PAIN CLINIC AND THEY SAID ¿UNH-UNH¿. THE DEVICE SYSTEM HAD BEEN USED TO DELIVER MORPHINE. THE PATIENT WAS THEN REPORTEDLY RE-IMPLANTED ON (B)(6) 2013. 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
    271754 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Required Intervention