BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3870695 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-11527
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    September 12, 2012
    Report Date
    May 23, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8711, LOT# J10854R52, IMPLANTED: (B)(6) 2001, PRODUCT TYPE CATHETER; PRODUCT ID 8709, LOT# J0056627R, IMPLANTED: (B)(6) 2000, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A MOTOR STALL AND "RESTART" OCCURRED. IT WAS CONFIRMED BASE ON LOGS. THE PATIENT WAS IN A HOLISTIC STORE AS WELL AS OTHER PLACES BUT THE HOLISTIC STORE WAS THE ONLY PLACE SHE KNEW THAT HAD MAGNETS AND "SHUT THE PUMP OFF". THE PATIENT WENT THROUGH WITHDRAWAL AND WENT TO THE ER. THE PUMP WAS INTERROGATED AND "RESTARTED AT THE HOSPITAL THAT SAME DAY AROUND 6 PM. AFTER THE PUMP WAS RESTARTED, IT WENT FROM 42 MONTHS ELECTIVE REPLACEMENT INDICATOR (ERI) TO 81 MONTHS. SINCE THEN, IT HAD BEEN COUNTING DOWN ACCURATELY FROM 81 MONTHS, BUT IT WAS NOT THE ACTUAL ERI. THE ERI CURRENTLY READ 60 MONTHS BUT, SHOULD SAY 22 MONTHS. NO OTHER MOTOR STALLS HAVE OCCURRED AND THE PUMP HAS NOT HAD ANY OTHER ISSUES SINCE. THE PUMP CONTAINED HYDROMORPHONE AND MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347921 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR