BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2120197 · Received June 6, 2011

    Report

    Report Number
    3004209178-2011-04049
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 26, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(4) 2011, IT WAS INITIALLY REPORTED THAT WITHIN A SHORT AMOUNT OF TIME FOLLOWING A REFILL SESSION, THE PT WAS NOT RESPONDING AND WAS OBTUNDED. IT WAS NOTED THAT THE EVENT WAS NOT DUE TO A PROCEDURE ISSUE. THE PHYSICIAN USED FLUORO FOR REFILLS, AND HAD ASPIRATED ALL OF THE FLUID FROM THE PUMP. THE PHYSICIAN ASPIRATED ALL 20ML OF DRUG FROM THE PUMP. NO DISCREPANCY WAS NOTED. THE PUMP WAS FILLED W/O ISSUE. IT WAS FURTHER INDICATED THAT THE RESERVOIR BELLOWS WERE FULLY EXPANDED. THE PT WAS GIVEN 0.2MG OF NARCAN (X1), AND SHE HAD RESPONDED WELL TO THIS. THE PT WAS NOTED AS ALSO TAKING ORAL PAIN MEDICATIONS. THE PT WAS ADMITTED TO A HOSPITAL FOR EVAL. THE FOLLOWING MEDICATIONS WERE DELIVERED VIA THE PUMP: FENTANYL, CLONIDINE, AND COMPOUNDED BACLOFEN. ON (B)(6) 2011, IT WAS FURTHER REPORTED THAT DURING THE REFILL APPROX 3 WEEKS AGO, SOME OF THE DRUG WENT INTO THE POCKET. OVERDOSE WAS REPORTED; AND THE PT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2011. IT WAS NOTED THAT THE PHYSICIAN DOES NOT WANT TO REFILL THE PUMP AGAIN. ADD'L INFO 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 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| R EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731, LOT# B003016N12