BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3131744 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08273
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    April 30, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8703W, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: (B)(4).

    Description of Event or Problem · 1

    THE PATIENT LATER REPORTED THAT THEY WERE STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY, BUT THEY WERE WORKING WITH THEIR DOCTOR OR REPRESENTATIVE. THEIR APPOINTMENTS WERE NOTED TO BE MONTHLY. THEIR LAST APPOINTMENT WAS ON (B)(6) 2013. THEIR NEXT APPOINTMENT WAS ON (B)(6) 2013.

    Description of Event or Problem · 1

    THE PATIENT STATED THAT ¿THEY HAD HAD MORE PROBLEMS WITH THEIR PUMP¿; THAT IT HANGS OUT OF THE ABDOMEN MORE; THAT IT WAS NOT PLACED AS WELL. THE PATIENT STATED THAT WHEN SHE WENT IN FOR HER REFILL ON (B)(6) 2013, IT TOOK HER HEALTHCARE PROVIDER THREE TIMES TO GET IT REFILLED, AND THAT AN ULTRASOUND WAS REQUIRED. THE PATIENT FURTHER STATED THAT, AS OF THE DATE OF THE REPORT, THE PUMP WAS WORKING ¿PAIN WISE¿. THE PATIENT STATED THAT THEIR PHYSICIAN HAD, LITTLE BY LITTLE, TAKEN AWAY SOME OF HER ORAL MEDICATIONS, SO HER PAIN HAD BEEN A LOT WORSE. THE PATIENT WAS NOTED TO HAVE WORN A POST-OP SURGICAL BAND OVER HER PUMP FOR A FEW MONTHS, AND THAT IT CAUSED SWELLING. THE PATIENT¿S PHYSICIAN STATED THAT ¿IT WAS JUST THE SWELLING; THEN THE WEIGHT LOSS; THEN THE SCAR TISSUE¿. THE PATIENT STATED THAT WHEN SHE BENT OVER, THE PUMP JUST HUNG, ¿ALMOST LIKE IT WAS GOING TO FLIP¿. THE PATIENT FURTHER STATED THAT HER PUMP ¿JUST FLOPPED AROUND¿ AND THEY COULD FEEL IT MOVING AS SHE MOVED. THE PATIENT WAS WEARING AN ABDOMINAL BINDER AT THE TIME OF THE REPORT. THE PATIENT LATER REPORTED THAT THE PUMP WAS LYING ¿ALMOST, LIKE, VERTICALLY INSTEAD OF HORIZONTALLY¿. IT WAS LATER REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY, BUT THEY WERE WORKING WITH THEIR DOCTOR. THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234580 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR