BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3203518 · Received July 3, 2013

    Report

    Report Number
    3004209178-2013-04768
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Report Date
    September 19, 2012
    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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN ALARM SOUNDING EVERY HOUR FOR 5 MONTHS. THE PATIENT HAD NOT SEEN HER HEALTH CARE PROVIDER SINCE 2008. SHE HAD A SERIOUS BACK CONDITION SINCE THE PUMP HAD BEEN EMPTY AND HAS BEEN ON CYMBALTA TO HELP WITH THE PAIN. THE ALARM HAD BEEN DISTURBING THE PATIENT¿S SLEEP PATTERN AND THE REST OF HER LIFE. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304703 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR