BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2231130 · Received August 26, 2011

    Report

    Report Number
    3004209178-2011-06946
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    January 1, 2011
    Report Date
    August 11, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PT WAS PLACED IN (B)(6); AND IT WAS NOTED THAT "THEY HAVE NOW BEEN TAKING OVER CARE" OF THE PT'S PUMP. SINCE BEING PLACED IN THE CORRECTIONAL FACILITY, THE PT EXPERIENCED BLACKOUTS AND INTERMITTENT NUMBNESS. THE PT'S DOSE WAS CHANGED IN (B)(6) 2011, "BEFORE HE CAME TO THEM". IT WAS NOTED THAT THERE WERE NO PUMP ALARMS; AND PROGRAMMING WAS CORRECT. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other ACCESSORY: MODEL 8590-1, LOT# N104418| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8711, LOT# N106217007