BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3203745 · Received July 3, 2013

    Report

    Report Number
    3004209178-2013-11241
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    February 18, 2013
    Report Date
    June 10, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: CATHETER MODEL: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: UNK; CATHETER MODEL: 8711 SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: UNK; PROGRAMMER; MODEL: 8840, SERIAL# UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    A MISSED REFILL AND EMPTY PUMP WAS REPORTED; DRUG DELIVERED VIA THE DEVICE WAS BACLOFEN (GABLOFEN 2000 MCG/ML, 450 MCG/DAY). REPORTER RECEIVED A MESSAGE UPON INTERROGATION STATING EMPTY RESERVOIR ALARM HAD SOUNDED ON (B)(6) 2013 AND A LOW RESERVOIR ALARM DATE WAS SET FOR (B)(6) 2013. REPORTER DID NOT KNOW WHY THE REFILL WAS MISSED. PATIENT HAD NOT REPORTED ANY SYMPTOMS, DENIED ANY BACLOFEN WITHDRAWAL SIGNS AND SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303784 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR