BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3181869 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10694
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 28, 2013
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID NEU_PTM_PROG, SERIAL# UNKNOWN; PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PUMP WAS ALARMING. THERE WAS A CONFIRMED, UNRECOVERED MOTOR STALL THAT OCCURRED ON (B)(6) 2013 AT 0139. THE PUMP MEDICATION WAS UNKNOWN. IT WAS LATER REPORTED, THE PATIENT HEARD AN ¿ODD, INTERMITTENT ALARM SOUND¿ COMING FROM THE PUMP. THE PATIENT STATED, HIS PAIN HAD BEEN ¿SO MUCH WORSE FOR THE LAST FEW DAYS.¿ WHEN THE PATIENT ATTEMPTED TO USE HIS PERSONAL THERAPY MANAGER (PTM) TWO DAYS PRIOR TO THIS REPORT DATE, HE RECEIVED THE ERROR CODE MESSAGE ¿8476¿. THE PATIENT STATED, ¿EACH ATTEMPT TO ADMINISTER A BOLUS TO COUNTERACT MY RISING PAIN LEVEL SINCE HAS RESULTED IN A FAILURE ACCOMPANIED BY THAT ERROR CODE.¿ THE PATIENT HAD A¿ TERRIBLE NIGHT¿ THE NIGHT FOLLOWING THIS EVENT DATE. THE PATIENT HAD PLANS TO FOLLOW UP WITH HIS HEALTH CARE PROVIDER THE DAY AFTER THIS REPORT DATE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT ON 2013-(B)(6), THE PATIENT HAD A PUMP REVISION. IT WAS NOTED THAT THE PATIENT HAS RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282912 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention