BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1920124 · Received December 8, 2010

    Report

    Report Number
    3007566237-2010-10322
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 1, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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 HCP (HEALTHCARE PROVIDER) FILLED THE PT'S PUMP ON (B)(6) 2010 AT 10:00 AM WITH A COMPOUNDED MIXTURE OF BACLOFEN 2000 MCG/ML AND DILAUDID 60 MCG/ML AND HAD PROGRAMMED A BRIDGE BOLUS TO INFUSE OVER 21 HOURS. BY 6 AM ON (B)(6) 2010, THE NEW DRUG HAD REACHED THE TIP OF THE CATHETER. THE PT WAS OBTUNDED BY 6PM ON (B)(6) 2010. THE PT WAS ADMITTED TO THE HOSPITAL ICU (INTENSIVE CARE UNIT) WITH SIGNS AND SYMPTOMS OF NARCOTIC OVERDOSE AND THEN WAS SUBSEQUENTLY TRANSFERRED VIA HELICOPTER TO A SPECIALTY CHILDREN'S HOSPITAL. THE DRUG RESERVOIR WAS ACCESSED AT 0200 ON (B)(6) 2010. THE PUMP MEDICATION WAS WITHDRAWN. A RESERVOIR RINSE WITH A TOTAL OF 10 ML OF PRESERVATIVE-FREE NORMAL SALINE WAS PERFORMED TWICE. THE HCP THEN REFILLED THE DRUG RESERVOIR WITH LIORESAL, 2,000 MCG/ML CONCENTRATION. IT WAS QUESTIONED WHETHER THE DILAUDID WAS AN INCORRECT CONCENTRATION SINCE THE PT DEMONSTRATED SIGNS AND SYMPTOMS OF DILAUDID OVERDOSE. THE MEDICATION WAS TO BE SENT OUT TO BE ASSAYED TO VERIFY THE CORRECT CONCENTRATION WAS MIXED. THE HCP DECIDED NOT TO PERFORM THE PROCEDURE TO CLEAR THE RESIDUAL MEDICATION FROM THE INTERNAL PUMP TUBING AND CATHETER. IT WAS BELIEVED THE POTENTIAL BENEFITS OF CLEARING THE MEDICATION OUT MAY NOT BE ADVANTAGEOUS AS THE PT HAD A HISTORY OF (B)(6). THE PUMP DRUG THAT CONTAINED DILAUDID WOULD HAVE CLEARED FROM THAT PUMP AND CATHETER BY (B)(6) 2010 AT 11:00 PM. THE PT WAS GIVEN A NARCAN IV CONTINUOUS INFUSION. THE PT IMMEDIATELY RESPONDED TO THE NARCAN AND AS OF (B)(6) 2010 AT 1:50 PM, THE PT WAS AWAKE AND ALERT. ADDITIONAL INFORMATION 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 MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| L| R IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8596SC, LOT# N108932015| EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8711, LOT# J10918R51