BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 426963 · Received November 6, 2002

    Report

    Report Number
    6000030-2002-00852
    Event Type
    Injury
    Date Received
    November 6, 2002
    Date of Event
    October 15, 2002
    Report Date
    October 29, 2002
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF A WITHDRAWAL EPISODE, REFILLED BY DR DAY AFTER WITHDRAWAL TO MAKE SURE PUMP WAS OK. FOLLOW UP WITH HCP REVEALED THAT PT HAD BEEN TO SEE A CHIROPRACTOR AND PARTICIPATED IN SOME "BALL" EXERCISE AND DEVELOPED WITHDRAWAL SYMPTOMS AFTER THAT TIME AND WENT TO THEIR LOCAL ER. VISIT WAS CONFIRMED BY HCP. PT REPORTED FOR THE REFILL AND HCP PERFORMED THE REFILL. THE DRUG CONCENTRATION WAS CHANGED AND A BRIDGE BOLUS WAS GIVEN. RESIDUAL VOLUME WAS APPROX 3.2ML. AN X-RAY WAS ORDERED OF THE CATHETER AND THE X-RAY REPORT INDICATED THAT THE CATHETER WAS UNCHANGED FROM PRIOR X-RAYS AT THAT FACILITY. THE PT TELEPHONED AND REPORTED THAT PT HAD "OVERDOSE AND WITHDRAWALS" THE NIGHT BEFORE, AFTER THE REFILL. PT COULD NOT RELATE ANY SYMPTOMS OTHER THAN THAT THEIR "BLOOD LEVELS WERE HIGH" WHEN PT WENT TO LOCAL ER AND ER PHYSICIANS GAVE NARCAN. IT WAS CONFIRMED THAT PT KAD VISITED ER AND HAD RECEIVED NARCAN. PT REPORTED TO CLINIC AND PT'S PUMP WAS REFILLED WITH NACI AND RESIDUAL VOLUME OF DILAUDID WAS APPROPRIATE TO TIME ELAPSED. PT WAS OBSERVED TO BE NOT AS "ANIMATED" AS PT HAD BEEN. PT CONTINUES TO BE MONITORED BY HCP WITH NACI IN PUMP. PT REQUESTING REMOVAL OF PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL IMPLANTABLE INFUSION PUMP LKK MEDTRONIC, INC. 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization CATHETER: MODEL 8703W, LOT#L44107, IMPLANT 1997,| EXPLANT UNK.