BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3002708 · Received March 13, 2013

    Report

    Report Number
    3007566237-2013-00771
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 12, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL#: (B)(4), PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL REVIEW REPORTED THAT POCKET FILLS WERE SUSPECTED. THE PATIENT'S HUSBAND HEARD IT SEVERAL TIMES DURING REFILLS. IT WAS NOTED THAT THERE WAS ONE TIME WHERE THE DRUG MISSED THE PUMP OR SOME OF THE DRUG DID NOT WENT INTO THE PUMP. THE PATIENT'S HUSBAND WAS CONCERNED THAT THE INTERNS WHO PERFORM THE REFILLS WERE NOT QUALIFIED. IT WAS ALSO REPORTED THAT ACCORDING TO PATIENT'S CHART, EVERY REFILL HAD BEEN WITHIN A ½ CC OF WHAT WAS EXPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE LAST SEVERAL PUMP REFILLS, THE PATIENT'S STOMACH WOULD BLOW UP LIKE A BALLOON. WHEN A CERTAIN PHYSICIAN FILLED THE PUMP, THE PATIENT NEVER HAD THE BLOATING. IT WAS NOTED THAT AT ONE TIME THE PHYSICIAN THOUGHT THE MEDICATION WAS PROBABLY MISSING THE PUMP, OR NOT ALL OF IT WAS ENTERING THE PUMP. THE PATIENT WOULD GET A SOFTBALL SIZE, MUSHY BALLOON ON HER STOMACH THAT WOULD VARY IN SIZE. IT WAS QUESTIONED IF THE PUMP COULD BE GETTING MISSED AND IF POCKET FILL COULD BE CAUSING THIS TO HAPPEN. THE PATIENT WOULD GET KNOCKED OUT FOR APPROXIMATELY 24 HOURS POST REFILL AND WAS LETHARGIC. THE PATIENT WAS LAST FILLED ON (B)(6) 2013 AND THE PATIENT'S STOMACH STILL HAD NOT GONE DOWN. THE PATIENT WAS SEEN BY A PHYSICIAN AT THEIR CLINIC ON THE DATE OF THIS REPORT AND THE PATIENT NOTED THAT NOTHING WENT WRONG WITH THAT REFILL. IT WAS NOTED THAT THE PUMP HAD NOT FLIPPED, AND IT WAS UNKNOWN IF THERE WERE ISSUES OF IT MOVING AROUND IN THE POCKET. THE PATIENT HAD AN UPCOMING APPOINTMENT TO DISCUSS THESE ISSUES WITH THEIR PHYSICIAN. THE DRUG IN THE PUMP WAS UNKNOWN. 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
    104855 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other