BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 2152980 · Received June 17, 2011

    Report

    Report Number
    3007566237-2011-04552
    Event Type
    Death
    Date Received
    June 17, 2011
    Date of Event
    January 1, 2010
    Report Date
    May 23, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED IN (B)(6) 2010 THAT THE PATIENT HAD AN INCREASE IN BASELINE PAIN DURING A NORMAL REFILL CYCLE. IT OCCURRED MULTIPLE TIMES. THE NEW PAIN WAS IN THE "MID BACK" AREA. THE PATIENT ALSO HAD AN INS IMPLANTED; THE PAIN WAS RESPONDING TO THE THERAPIES. THE PATIENT WAS AT HOME AND REPORTED STATUS TO BE FAIR. IT WAS ALSO REPORTED THAT THE HCP PLANNED TO PERFORM A DRUG OR CONCENTRATION CHANGE PROCEDURE: THEY PLANNED A RESERVOIR RINSE PROCEDURE. THE HCP HAD INFORMED THE PATIENT THAT HE MAY GO THROUGH WITHDRAWAL FOR "2 WEEKS" AFTER DRUG WAS CHANGED IN THE PUMP. AT THE TIME OF THIS REPORT, MORPHINE WAS THE "CURRENT" DRUG; HYDROMORPHONE WAS THE "NEW" DRUG. IT WAS LATER REPORTED BY THE HCP THAT IT WAS BELIEVED THAT THE PATIENT DIED ON (B)(6) 2010 AND THEY HAD NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J12238R11