BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3842819 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09945
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    May 28, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: CATHETER. PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, WHEN DISCUSSING AN EMPTY PUMP, THIS ALMOST HAPPENED AGAIN LAST MONTH. THE PATIENT DID NOT HAVE REFILL INFORMATION OR A PRINTOUT, WHICH USUALLY HELPED HER. THE PATIENT¿S HEALTHCARE PROVIDER (HCP) ¿GOT HER IN RIGHT AWAY¿ FOR A REFILL. THE PATIENT WAS ¿HAVING ISSUES¿ AND WAS ¿NOT FEELING RIGHT¿ BECAUSE THE PUMP WAS ALMOST EMPTY IN TWO DAYS. THE PATIENT CONTACTED HER HCP AND SHE WAS TOLD THAT ¿IT WAS HER FAULT TO NOT REMEMBER THE REFILL DATE BECAUSE SHE DID NOT GET A PRINTOUT¿. AT THE PATIENT¿S LAST REFILL ON (B)(6) 2014, THE PUMP DOSE WAS UPDATED FROM 96.78 TO ¿100 SOMETHING¿. IT WAS NOTED THAT, AT THE TIME OF THE REPORT, THE PATIENT SEEMED CONFUSED AND DISORIENTED AT TIMES. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. PLEASE SEE MANUFACTURER REPORT # 3004209178-2013-15844 FOR INFORMATION REGARDING THE EMPTY PUMP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. IT WAS FURTHER REPORTED THERE SEEMED TO BE A LIMITED NUMBER OF PHYSICIANS TO DO PUMP REFILLS. IT WAS NOTED THE PATIENT HAD POST-PONED HAVING MAGNETIC RESONANCE IMAGING (MRI'S) DUE TO THE LOCATION OF THE DOCTOR TO RECHECK THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320873 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR