BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2052527 · Received April 11, 2011

    Report

    Report Number
    3004209178-2011-02723
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 2, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT WAS ADMITTED TO THE HOSPITAL FOR SYMPTOMS CONSISTENT WITH BACLOFEN WITHDRAWAL AND UTI; THE PT WAS BEING TREATED FOR BOTH. THE PUMP WAS INTERROGATED; THERE WERE NO ALARMS. THE PUMP HAD BEEN FILLED THE PREVIOUS WEEK, SO THE PHYSICIAN SUSPECTED THERE COULD HAVE BEEN A PROBLEM WITH THE REFILL. THE PHYSICIAN EMPTIED AND REFILLED THE PUMP; HE FOUND THE VOLUME TO BE ACCURATE. THE PUMP WAS REFILLED WITH NEW DRUG. THE NEXT DAY, PT'S TREMORS OR SPASMS THAT PEOPLE WERE SEEING HAD RESOLVED; THE PT WAS STABLE. SHE WAS TO BE WORKED UP FOR A SUSPECTED UTI. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization EXPLANTED:| CATHETER: MODEL 8709, LOT# J0056621R| IMPLANTED: