BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1943664 · Received December 21, 2010

    Report

    Report Number
    3004209178-2010-10650
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 10, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. AN UNUSUAL SKIN DISCOLORATION WAS NOTED ON THE INCISION LINE AT PUMP REFILL ON (B)(6) 2010; THE "SKIN BROKE" ON (B)(6) 2010. INITIALLY, THE PATIENT HAD "GREENISH DRAINAGE"; AT THE TIME OF THE REPORT, THE DRAINAGE WAS NOTED TO BE "MORE BLOODY". THE AREA WAS THE SIZE OF A PENCIL ERASER. THE PATIENT WAS GIVEN MEDICATION; KEFLEX 500 MG, 4/DAY. THE PATIENT PLANNED TO SEE THE HCP ON (B)(6) 2010. AN OPERATING ROOM WAS RESERVED FOR (B)(6) 2010 FOR POSSIBLE REMOVAL OF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention IMPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N250540| EXPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N252942007