BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 2190341 · Received July 25, 2011

    Report

    Report Number
    6000030-2011-05728
    Event Type
    Injury
    Date Received
    July 25, 2011
    Report Date
    July 6, 2011
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2009, IT WAS REPORTED THAT "OVER THE PAST YEAR THE PUMP HAD NOT PROVIDED MUCH PAIN RELIEF, EVEN AFTER THE PHYSICIAN HAD INCREASED THE DOSAGE OF MEDICATION." AROUND 6 TO 9 MONTHS PRIOR THE "PHYSICIAN WAS UNABLE TO FIND THE ACCESS PORT." THE PATIENT WAS AT HOME AT THAT TIME AND WAS NOT AWARE OF ANY COMPLICATIONS WITH REFILLING THE PUMP. IT WAS STATED THAT THE PHYSICIAN NEVER WITHDREW MEDICATION BUT ONLY INFUSED NEW MEDICATION IN THE PUMP. HCP OPTIONS WERE BEING CONSIDERED. ON (B)(6) 2011 IT WAS REPORTED THAT THE PUMP WAS REMOVED IN (B)(6) 2009 DUE TO AN "INFLAMMATORY MASS AT T8-T10." "THE PUMP WAS PUT BACK IN (B)(6) 2010 AND THEN REMOVED IN (B)(6) 2010." HCP OPTIONS WERE BEING CONSIDERED AGAIN. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| CATHETER: MODEL 8709, LOT# J10894R15| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT# UNKNOWN| EXPLANTED: