BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2143003 · Received June 23, 2011

    Report

    Report Number
    3004209178-2011-04692
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 26, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    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 A PT HAD BEEN SEDATED AND NAUSEATED. THE HCP CHANGED THE CONCENTRATION OF DILAUDID IN THE PUMP FROM 4 MG/ML TO 1 MG/ML. THERE WAS REDNESS AT THE PUMP SITE AND A CULTURE WAS POSITIVE FOR (B)(6). THE SYSTEM WAS EXPLANTED ON (B)(6) 2011. THE PT RECOVERED WITHOUT SEQUELAE. ADD'L INFO WILL BE REPORTED IF IT 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 76 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N280240006| EXPLANTED: