BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2881984 · Received December 20, 2012

    Report

    Report Number
    3007566237-2012-03082
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Report Date
    November 23, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT# J10910R52, IMPLANTED: (B)(6) 2002, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS MISSED AND THE PUMP WAS AT AN END-OF-SERVICE (EOS) STATUS. THE PUMP HAD BEEN AT EOS SINCE (B)(6) 2012. A TUBE SET MESSAGE WAS ALSO REPORTED. THE PATIENT WAS LAST SEEN IN SPRING OF 2012. THE PUMP WAS ALARMING, BUT HADN'T BEEN ALARMING FOR 3 MONTHS. THE PATIENT HAD BEEN HEARING THE ALARM FOR ABOUT FOUR WEEKS. THE DRUG BEING USED IN THE PUMP WAS LIORESAL OR GABLOFEN. IT WAS NOTED THE PATIENT HAD BEEN ON AN EXTREMELY LOW DOSE. THE PATIENT WAS A LITTLE TIGHTER THAN NORMAL, BUT WAS DOING FINE AND THERE WERE NO THERAPY ISSUES AS OF (B)(6) 2012. THE PATIENT WAS SCHEDULED TO BE SEEN (B)(6) 2013. IT WAS UNCLEAR IF THE PUMP WAS GOING TO BE REPLACED AT THAT TIME. THE PATIENT WAS GOING TO BE PRESCRIBED ORAL BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP HAD TURNED ITSELF OFF AND WAS OFF AT THE TIME OF REPORT. THE PATIENT HAD NOT EXPERIENCED CHANGE IN CLINICAL CONDITION AND NO HOSPITALIZATION WAS REQUIRED. IT WAS NOTED THAT PUMP REMOVAL WAS BEING CONSIDERED. THE DRUG USED IN THIS SYSTEM WAS LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1