BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3186105 · Received June 24, 2013

    Report

    Report Number
    3004209178-2013-10795
    Event Type
    Malfunction
    Date Received
    June 24, 2013
    Report Date
    May 31, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0591-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8590-1, LOT# N191985, IMPLANTED: 2009-(B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID 8731, SERIAL# (B)(4), IMPLANTED: 2004-(B)(6), (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, A COUPLE OF WEEKS PRIOR TO REPORT, THE PATIENT HAD A MOTOR STALL DUE TO AN MRI. IT WAS STATED THAT THE PUMP HAD NOT BEEN INTERROGATED UNTIL (B)(6), AT WHICH TIME THERE WAS NO MOTOR STALL RECOVERY AND ¿STOPPED PUMP PERIOD MAY EXCEED TUBE SET¿ WAS DISPLAYED IN THE LOGS. IT WAS NOTED THAT THE DEVICE INTERROGATION OCCURRED DUE TO A DOSE INCREASE TO THE PUMP. THERE WAS NO CHANGE IN SYMPTOMS REPORTED AND IT WAS STATED THAT THE DOSE INCREASE HAD BEEN PLANNED PRIOR TO THE MOTOR STALL OCCURRING. THE DEVICE SYSTEM HAD BEEN USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286408 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1