BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3181900 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10699
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 28, 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
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PROGRA CATHETER MODEL: 8596, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: UNK; CATHETER MODEL: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: UNK; MMER MODEL: 8835 SERIAL# NPG033363N. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT INDICATED THAT PUMP HAD FLIPPED ¿UPSIDE DOWN¿. PATIENT WAS SCHEDULED TO HAVE A MRI TO CONFIRM THE SAME, AND COMPATIBILITY GUIDELINES WERE REQUESTED. IT WAS STATED THAT PATIENT HAD HAD MRIS IN THE PAST. TWO DAYS LATER IT WAS REPORTED THAT PATIENT HAD CHRONIC PAIN AND HISTORY OF BACK SURGERY AND THEY WERE TO SCAN HER FOR PAIN ISSUES ON (B)(6) 2013. IT WAS LATER REPORTED THAT THE MRI FACILITY WAS RELUCTANT TO SCAN PATIENT, THERE WAS NO EVENT. PATIENT OUTCOME WAS STATED AS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282081 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR