BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2032468 · Received March 25, 2011

    Report

    Report Number
    3004209178-2011-02313
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    March 1, 2010
    Report Date
    March 10, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD INCREASED DRAINAGE FROM HER LUMBAR AREA INCISION SITE. THE PT WAS DIAGNOSED WITH A SUPERFICIAL WOUND INFECTION. THE PUMP AND CATHETER WERE EXPLANTED. THE PT RECOVERED WITHOUT SEQUELA. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    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 62 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N255698010| EXPLANTED:| PROGRAMMER: MODEL 8835, LOT# NPG016746N| IMPLANTED:| CATHETER: MODEL 8598A, LOT# N257272002| EXPLANTED: