BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3923591 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-12747
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 18, 2014
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8703W, SERIAL# L41861, IMPLANTED: 1997 (B)(6); PRODUCT TYPE CATHETER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE HEALTHCARE PROVIDER (HCP) HAD A DIFFICULT TIME FILLING THE PUMP BECAUSE, IT WAS TILTED, BUT DID NOT HAVE FLUOROSCOPY (FLUORO). IT WAS NOTED, THE PATIENT WAS LOOKING FOR A CLOSER DOCTOR WHO USED FLUORO TO MAKE HER REFILLS EASIER. IT WAS ALSO REPORTED THE PATIENT EXPERIENCED WITHDRAWAL BECAUSE HER LAST REFILL WAS DIFFICULT AND THE PUMP WAS EMPTY. THE PATIENT WAS CONCERNED THAT THIS REFILL WOULD NOT GO WELL AND IT WILL HAPPEN AGAIN. THIS EVENT WAS ALSO REPORTED UNDER MANUFACTURER REPORT # 3004209178-2013-16530 [IT WAS REPORTED THAT THE PATIENT HAD A SURGERY SCHEDULED FOR THE 2013 (B)(6). THE PATIENT WENT TO HER HEALTHCARE PROVIDER (HCP) BECAUSE, SHE WAS HAVING A LOT OF ANXIETY. THE HCP BELIEVED IT WAS DUE TO STRESS. THE PATIENT WAS TO HAVE A NUCLEAR SEDENTARY STRESS TEST ON THE DAY OF THE REPORT. IT WAS ALSO REPORTED THAT THE PUMP WAS ¿ALWAYS REALIGNED AND SURGICALLY PUT¿ AND IT TENDED TO FLIP. THE SUTURES RIPPED AND IT WENT TO ITS SIDE AND STUCK OUT OF THE PATIENT¿S STOMACH. THE PATIENT HAD SURGERIES TO CORRECT THIS. THE PATIENT HAD ¿BATTLES¿ WITH TELEMETRY. IT WAS NOTED THAT THE PATIENT WAS DUE FOR A REFILL AND HAD 3ML LEFT IN THE RESERVOIR. THE PATIENT HAD HER PUMP REFILLED TWO WEEKS AGO. IT WAS NOTED THAT THE PATIENT WAS SEDENTARY AND DISABLED. IT WAS REPORTED THAT THE PATIENT HAD A MORPHINE PUMP.] ANY ADDITIONAL INFORMATION RECEIVED WILL BE REPORTED UNDER THIS MANUFACTURER REPORT NUMBER. ADDITIONAL INFORMATION RECEIVED REPORTED ¿THEY HAVE NEVER BEEN ABLE TO GET THE PUMP TO LAY FLAT AND IT DIDN¿T MATTER IF SHE WAS 160 OR 260 POUNDS.¿ IT WAS NOTED, THE PUMP WOULD NOT FLIP, BUT THE RIM OF THE PUMP ¿STICKS OUT LIKE A BABY¿S FOOT.¿ IT WAS ALSO REPORTED THEY HAD DONE MANY REVISIONS OTHER THAN BATTERY REPLACEMENTS TRYING TO GET THE PUMP TO LAY FLAT. IT WAS REPORTED, THE PATIENT DID NOT WANT THE PUMP MOVED TO THE OTHER SIDE. IT WAS UNKNOWN WHEN THE REVISIONS WERE. IT WAS ALSO REPORTED SOMETIME IN 2011 THE HCP GAVE THE PATIENT 60 MILLIGRAMS (MG) OF NS CONTIN AND SENT HER FOR FLUOROSCOPY (FLUORO) TO SEE IF THE PUMP WAS FLIPPED OTHER THAN JUST ON ITS SIDE, BUT THEY WERE NOT ABLE TO DO THE FLUORO. IT WAS FURTHER REPORTED ¿IN THE WAY BEGINNING¿ THE PATIENT WOULD HAVE A HOME NURSE FILL HER PUMP AND THE NURSE ALSO HAD A HARD TIME FILLING THE PUMP, BUT THE PATIENT WOULD SUFFER THROUGH THE PAIN SO SHE WOULD NOT HAVE TO GO HAVE ¿FLUORO¿ DONE. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399663 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention