BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2792622 · Received October 16, 2012

    Report

    Report Number
    3004209178-2012-09219
    Event Type
    Injury
    Date Received
    October 16, 2012
    Report Date
    September 21, 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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALARM WAS HEARD AND WAS CONFIRMED BY TELEMETRY. THE PATIENT HEARD THE ALARM BUT DID NOT REALIZE IT UNTIL THE DAY PRIOR TO THE REPORT AND MISSED THE PUMP REFILL DATE OF (B)(6) 2012. THE PATIENT WAS SENT TO THE EMERGENCY ROOM DUE TO THE ALARM AND WAS ADMITTED TO THE HOSPITAL ON (B)(6). THE PUMP WAS REFILLED AND PROGRAMMED WITH THE SAME RATE OF (B)(6). THE PATIENT WAS ASYMPTOMATIC WITH NO SIGNS OF WITHDRAWAL AND WAS STABLE. THE PATIENT OUTCOME WAS REPORTED AS NO INJURY AND RECOVERED WITHOUT SEQUELAE. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL (BACLOFEN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization