BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202139 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-01076
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    April 12, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A NEW DRUG INFUSION PUMP IMPLANTED IN 2009. THE PATIENT STATED THE SERIAL NUMBER WAS (B)(4). HOWEVER, THE SERIAL NUMBER WAS LISTED AS THE PUMP THAT WAS IMPLANTED IN 2005. THE MANUFACTURER¿S REPRESENTATIVE WAS UNAWARE OF ANY NEW IMPLANT FOR THIS PATIENT. THE PATIENT STATED HIS PUMP WAS SHUTTING DOWN AND HE NEEDED A NEW PHYSICIAN TO REPLACE IT. THE PATIENT WAS EXPERIENCING WITHDRAWAL, UPSET STOMACH, THROWING UP, FEVER, AND HIS LEGS WERE STARTING TO SPASM AND ¿JUMP OFF THE BED.¿ THE PATIENT FELT HIS BATTERY WAS GOING DEAD AND THAT HIS DAILY DOSE WAS 2.75 ML PERDAY. THE PATIENT¿S HEALTH CARE PROVIDER REFUSED TO REPLACE THE PUMP BECAUSE THE PATIENT WAS ON PLAVIX DUE TO A STENT IMPLANT NOT RELATED TO THE PUMP. THE PATIENT ALSO HEARD ALARM. HE WAS HEARING A SIREN ALARM FOR THE PAST 3 WEEK PRIOR TO THE CALL. IT WAS NON-CRITICAL ALARM IN THE BEGINNING OF (B)(6) 2012. THERE WAS NO PLAN TO ADDRESS THE WITHDRAWAL. THE PATIENT STATED HE ONLY HAD PRIVALT IN HIS PUMP. THE REFILL WAS LESS THAN 3 WEEKS AWAY ON THE CALL DAY. THE PATIENT OUTCOME WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300944 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1