BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2120031 · Received June 8, 2011

    Report

    Report Number
    3004209178-2011-04140
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    March 1, 2011
    Report Date
    May 11, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT WAS SEEN IN THE CLINIC ON (B)(6) 2011 AND THEY HAD DIFFICULTY REFILLING THE PUMP. AN X-RAY WAS DONE AND IT WAS CONFIRMED THAT THE PUMP WAS FLIPPED. THE PT WENT TO SURGERY ON (B)(6) 2011 AND THE PUMP WAS FLIPPED BACK AND REFILLED. THE PT OUTCOME WAS REPORTED AS A "NON-SERIOUS INJURY/ILLNESS." THE DEVICE SYSTEM WAS USED TO DELIVERY LIORESAL.

    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 74 YR Required Intervention EXPLANTED:| EXPLANTED:| LOT #NGV007784N| CATHETER: MODEL 8731, LOT #N002293010| IMPLANTED:| EXPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 863740,| LOT #NGV007784N| IMPLANTED:| IMPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 863740,