BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2981341 · Received February 27, 2013

    Report

    Report Number
    3004209178-2013-03125
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    January 31, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATHETER: MODEL 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD REFILL APPOINTMENT (B)(6) 2012, AT WHICH TIME IT WAS DISCOVERED THE PUMP HAD "FLIPPED UPSIDE DOWN." A REVISION WAS PERFORMED ON (B)(6) 2012, THE PUMP WAS NOT FILLED AT THE TIME OF THE REVISION, WHICH WAS NOT COMMUNICATED TO THE FOLLOW UP PROVIDER. IT WAS NOTED THAT THE "FIRST FEW DAYS AFTER SURGERY" THE PATIENT CALLED THE CLINIC STATING SHE THOUGHT THE PUMP "WAS SET TOO HIGH," THAT SHE "COULDN'T EVEN WAKE UP," "COULDN'T GET OUT OF BED," "COULDN'T THINK STRAIGHT," TO WHICH THE CLINIC "REPEATEDLY" TOLD THE PATIENT TO GO IN SO THEY COULD READ THE PUMP "SO THEY WOULD KNOW WHEN HER NEXT REFILL WOULD BE." IT WAS THEN NOTED THAT THE PATIENT "DOESN'T HAVE RIDES A LOT," AND "FINALLY" WAS SEEN ON (B)(6) 2013 FOR A REFILL, AT WHICH TIME THE PATIENT HAD "A LITTLE BIT OF PAIN," BUT WAS "OKAY." THE PUMP LOGS CONFIRM LOW RESERVOIR ALARM OCCURRED ON (B)(6) 2012 AND RESERVOIR EMPTY OCCURRED ON (B)(6) 2013. THE CLINIC DID NOT HAVE DRUG ON HAND TO FILL THE PUMP. THE PATIENT HAD ORAL MEDICATION THAT SHE "COULD TAKE IF SHE NEEDED IT." THE PUMP WAS FILLED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84321 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention