BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2003693 · Received February 24, 2011

    Report

    Report Number
    3004209178-2011-01387
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN INFECTION AT THE BACK INCISION SITE WAS OBSERVED. THE PHYSICIAN HAD CATHETER REPLACEMENT IN MIND AT THE START OF THE SURGERY BUT SEEING THAT THERE WAS NO ANOMALY IN THE CATHETER AROUND THE ANCHORING, PERFORMED DEBRIDEMENT OF THE AREA AND LEFT THE CATHETER IN SERVICE. THE DEVICE SYSTEM WAS USED TO DELIVER GABALON. 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 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention CATHETER: MODEL 8711, LOT# N208162022.| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8711, LOT# N208162022| EXPLANTED: