BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3811394 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-08956
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8840, SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 8709, LOT # J10811R38, IMPLANTED: (B)(6) 2001, PRODUCT TYPE CATHETER; PRODUCT ID 8578, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A ROUTINE PUMP REPLACEMENT PROCEDURE THE PATIENT BECAME LETHARGIC AND WAS ADMITTED TO THE HOSPITAL; THEY WERE SUSPECTING ACUTE RENAL FAILURE. THE ROUTINE PUMP REPLACEMENT WAS UNEVENTFUL. THE OLD PUMP WAS PROGRAMMED TO DELIVER DILAUDID (10MG/ML AT 6.98MG/DAY), BUPIVACAINE (30MG/ML AT 20.96MG/DAY), AND CLONIDINE (60MCG/ML AT 41.92MCG/DAY). THE NEW PUMP WAS PROGRAMMED THE SAME; HOWEVER, UPON FURTHER REVIEW OF THE MEDICATION THE NEW PUMP WAS FILLED WITH DILAUDID (20MG/ML), BUPIVACAINE (30MG/ML), AND CLONIDINE (120MCG/ML), SO THE PUMP WAS DELIVERING A DOUBLE DOSE OF THE CLONIDINE AND DILAUDID. THE PHYSICIAN OPTED TO REDUCE THE INTENDED DOSE (6.98MG/DAY) BY 10% TO 6.282MG/DAY. THE PATIENT HAD BEEN RECEIVING TWICE THE DOSE OF CLONIDINE AND DILAUDID FOR APPROXIMATELY 24 HOURS BEFORE THE PROGRAMMING WAS CORRECTED. IT WAS LATER REPORTED THAT THE PATIENT WAS DOING FINE NOW. THIS REPORTER DID NOT KNOW IF THE PATIENT HAD RENAL FAILURE. THE PATIENT HAD SOME OTHER ISSUES UNRELATED TO THE PUMP, BUT WAS DOING FINE NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290485 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization| R