BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3172062 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10426
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 20, 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
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    DRUG DELIVERED VIA THE DEVICE WAS MORPHINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PUMP REFILL PROCEDURE IT WAS DETERMINED THAT THE PATIENT¿S PUMP WAS FLIPPED. THIS WAS NOTICED IN (B)(6) 2013 THE FIRST REFILL FOLLOWING IMPLANT. PATIENT¿S PUMP WAS NOT FILLED AS PER REPORTER THERE WAS ENOUGH MEDICATION IN THE PUMP TO LAST UNTIL (B)(6) 2013. THE PUMP POCKET WAS REVISED AND THE PUMP WAS SECURED ON (B)(6) 2013. INITIALLY THE PUMP WAS AT THE WAIST LINE, DURING REVISION SURGERY THE POCKET WAS MADE BIGGER AND THE PUMP WAS MOVED UP AND STITCHED IN BETTER. PATIENT WORE AN ELASTIC BAND FOLLOWING SURGERY TO HELP HOLD THE PUMP IN PLACE AND ALSO ¿BECAUSE OF ALL THE SCAR TISSUE OF WHERE THE PUMP IS PLACED AT¿; HOWEVER PATIENT ¿FELT CHANGES IN PUMP POSITION, BUT WAS NOT SURE ABOUT IT AS HE DIDN¿T FEEL IT MOVE WHEN HE TOOK THE BRACE OFF FOR A SHOWER¿. PATIENT COULDN'T FEEL THE PUMP WHERE IT WAS AT PRIOR TO THIS SO FELT THAT ¿MAYBE IT'S JUST TRYING TO GET ADJUSTED TO IT BECAUSE IT TOUCHES HIS BOTTOM RIB ON RIGHT SIDE¿. PATIENT ALSO NOTED AN ERROR CODE 8987 (A DOWNLINK ERROR) ON THE PROGRAMMER AT THE SAME TIME AND STATED THAT¿S WHEN ¿EVERYTHING STARTED GOING DOWNHILL BECAUSE PUMP HAD FLIPPED AND HE HAD TO HAVE SURGERY AGAIN¿. PATIENT SAW THE SAME ERROR CODE ON (B)(6) 2013; PATIENT HAD A HCP APPOINTMENT ON (B)(6) 2013 FOR A PUMP REFILL. EMI (ELECTROMAGNETIC INTERFERENCE) SOURCES WERE DENIED. THE PUMP HAD BEEN HELPING PATIENT WITH PAIN AND HE ONLY TOOK TYLENOL AND ADVIL FOR ORAL PAIN MEDICATION BECAUSE OF OTHER MEDICAL ISSUES; WITHOUT OTHER ORAL PAIN MEDS AND CURRENT SETTING OF PUMP WITH BOLUSES PATIENT HAD SOME PAIN WHICH WAS STATED TO BE RELATED TO WEATHER AND OTHER CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274462 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00034 YR Required Intervention