BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 5211441 · Received November 9, 2015

    Report

    Report Number
    3004209178-2015-22449
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Report Date
    October 19, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8590-1, LOT# N162503, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID 8709SC, LOT# N188947002, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP), CONSUMER AND A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING INTRATHECAL BACLOFEN 2000 MCG/ML; 315 MCG/DAY VIA AN IMPLANTED PUMP. THE PUMP'S INDICATION FOR USE (IFU) WAS LISTED AS INTRACTABLE SPASTICITY AND STROKE. THE EVENT DATE WAS (B)(6) 2014. AN ALARM OCCURRED DUE TO AN EMPTY PUMP. IT WAS UNKNOWN IF THE PATIENT MISSED A REFILL, BUT THE PUMP WAS NOT FILLED WHEN IT SHOULD HAVE BEEN. THE CAUSE OF THE EMPTY PUMP WAS NOTED TO BE "THE PATIENT WAS LOST TO FOLLOW UP". NO SYMPTOMS WERE REPORTED. PER THE PRINT REPORT THE PUMP WAS LAST EXAMINED (B)(6) 2015 AND THE LAST CHANGE WAS (B)(6) 2014. THE AMOUNT DISPENSED SINCE THE LAST UPDATE WAS 31 ML. IT WAS BELIEVED THE EMPTY RESERVOIR ALARM MAY HAVE OCCURRED AROUND (B)(6) 2015. THE PATIENT HAS BEEN GOING WITHOUT DRUG AND NOW THEY WANT TO FILL THE PUMP TO START THE PATIENT ON THE THERAPY. NO OTHER ACTIONS HAVE BEEN TAKEN AS OF YET. FOLLOW UP WAS PENDING. SPECIFIC PATIENT SYMPTOMS, CAUSE OF THE EVENT, INTERVENTIONS, TROUBLESHOOTING/DIAGNOSTICS, TYPE OF BACLOFEN, LOT NUMBER, THERAPY DATES AS WELL AS CONCOMITANT DRUGS AND PATIENT OUTCOME WERE NOT REPORTED; ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742711 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR