BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3071235 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06666
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 26, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT WHEN SHE HAD GONE IN FOR HER LAST REFILL, THEY DETERMINED THAT 'THERE WAS NO LIQUID THAT HAD COME OUT SINCE SURGERY NO BACLOFEN AT ALL.' THE PATIENT STATED THAT 'THEY HAD LOOKED AT IT' AND DETERMINED THAT 'IT WAS STILL ATTACHED TO THE PUMP, AND WAS STILL ATTACH TO HER SPINE.' THE PATIENT STATED THAT SHE HAD HER DOSE RAISED FOUR TIMES, AND FURTHER STATED THAT THEIR HEALTHCARE PROVIDER HAD INCREASED IT TEN PERCENT AT ONE POINT. THE PATIENT STATED THAT WHEN SHE WENT IN, HER PUMP 'SUPPOSEDLY, GOING TO, RUN OUT' AND SHE WAS SUPPOSED TO HAVE ONLY 0.2 FLORAL OUNCES (5.9 ML) BUT 'NO LIQUID HAD LEFT, AT ALL' AND 'THE WHOLE, INITIAL DOSAGE OF FLUID WAS STILL IN THERE.' THE PATIENT INDICATED THAT THEY HAD PERFORMED AN IMAGING TEST, BUT 'THEY COULD NOT SEE ANYTHING' THOUGH THE PATIENT WAS 'STILL HOOKED IN FRONT AND BACK.' THE PATIENT HAD BEEN TAKING ORAL BACLOFEN. THE PATIENT STATED THAT THEIR HCP WANTED TO 'OPEN THE PATIENT UP IN FRONT TO SEE IF THERE WAS A KINK, BUT IF THERE WAS NOT ONE THERE, THEY WANTED TO GO IN ON THE BACK.' NO SURGERY WAS YET SCHEDULED. NO PATIENT SYMPTOMS WERE REPORTED. (B)(4); THE DOCUMENT CONTAINED NO NEW RELEVANT INFORMATION.

    Description of Event or Problem · 1

    CORRECTION: AFTER THE PATIENT'S SYSTEM WAS CHECKED AND REVEALED THAT THE PATIENT WAS STILL "HOOKED IN FRONT AND BACK," THE PATIENT STATED "THAT'S WHY I'M--LET'S FACE IT, I'M DEPRESSED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171392 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1