BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3092145 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07255
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 10, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT AT IMPLANT, THE PATIENT HAD ASKED FOR THE SMALLER PUMP, BUT THE LARGER PUMP WAS IMPLANTED INSTEAD SO THAT HE DIDN¿T NEED TO COME IN FOR REFILLS AS OFTEN. THE PUMP WAS REMOVED. THE STITCHES WERE REMOVED ON (B)(6) 2013. THE PATIENT WAS STILL HAVING SOME PAIN ON HIS RIGHT SIDE, BUT HADN¿T HAD ANY PROBLEMS WITH THE TINGLING IN HIS RIGHT LEG. PRIOR TO THE PUMP REMOVAL, THE PATIENT WOULD FEEL THE TINGLING DOWN HIS LEG, SOMETIMES WHEN HE CROSSED HIS LEGS, SOMETIMES WITH HIS FEET FLAT ON THE FLOOR, AND SOMETIMES WHEN HE WAS LYING DOWN. IT WAS NOTED THAT HIS RIGHT LEG WAS 2.5 INCHES SHORTER THAN HIS LEFT LEG BECAUSE OF THE INFANTILE POLIO THAT HE HAD. IT WAS ALSO NOTED THAT THE PATIENT WAS CURRENTLY HAVING MULTIPLE ISSUES RELATED TO HIS POST-POLIO SYNDROME AND HAD MULTIPLE SURGERIES RELATED TO IT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER RECEIVED PAIN RELIEF FROM THE PUMP SINCE IMPLANT IN (B)(6) 2012. IT WAS STATED THAT THE PATIENT HAD "EVEN MORE PROBLEMS" SINCE THE INFUSION PUMP IMPLANT. IT WAS SAID, THE PATIENT HAD A HISTORY OF POLIO AS AN INFANT, WHICH RESULTED IN LEG ATROPHY. DUE TO THIS, THE PATIENT HAD 'OCCASIONS WHEN HE FALLS". THE LOCATION OF THE PUMP WAS ON THE PATIENT'S RIGHT SIDE. IT WAS SAID, WHEN THE PATIENT SLEPT ON HIS RIGHT SIDE, THE AREA ROUND THE PUMP WOULD "SWELL". CHANGING POSITIONS WOULD ALLEVIATE THE SWELLING. THE PATIENT STATED THIS HAPPENED "ALMOST EVERY NIGHT", MAKING IT DIFFICULT TO SLEEP AT NIGHT. THE PATIENT STATED IT WAS UNCOMFORTABLE. THE PATIENT ALSO REPORTED OCCASIONAL DOUBLE VISION THAT CAME AND WENT. IT WAS SAID THAT IT WOULD COME ON "ALL OF A SUDDEN" AND THEN DISAPPEAR. THE PATIENT ALSO HAD A TINGLING/TREMBLING SENSATION IN HIS SPINE AROUND THE CATHETER AREA. IT WAS SAID, THE TINGLING/TREMBLING SENSATION WENT DOWN HIS BACK AND INTO HIS RIGHT LEG. THE PATIENT ALSO HAD REPORTED A DECREASED IN HIS SEX DRIVE/A PROBLEM WITH HIS LIBIDO. IT WAS NOTED THAT BEFORE THE PUMP WAS IMPLANTED, HE HAD "NORMAL SEX". THE PUMP WAS TURNED OFF IN (B)(6) 2013, BECAUSE THE PATIENT DIDN'T LIKE THE AFOREMENTIONED SIDE EFFECTS, AND WAS AFRAID THAT ONE OF HIS FALLS MIGHT DISLODGE THE CATHETER. SINCE HAVING THE PUMP TURNED OFF, THE TINGLING SENSATION HAD STOPPED, AND HIS LIBIDO HAD IMPROVED. HOWEVER, THE PATIENT'S LIBIDO "WASN'T LIKE IT USED TO BE". THE PATIENT WAS ABLE TO GET AN ERECTION WITH ASSISTANCE FROM CIALAS. THE PATIENT DID NOT REQUIRE ANY ASSISTANCE PRIOR TO GETTING THE PUMP. THE PATIENT STILL HAD DOUBLE VISION AND THE SWELLING WHEN SLEEPING. THE PATIENT WAS SCHEDULED TO HAVE THE PUMP REMOVED BECAUSE IT WASN'T "DOING HIM ANY GOOD". THE PUMP WAS DELIVERING MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193700 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention