BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3112967 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07674
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 17, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER; PRODUCT ID 8840, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TELEMETRY WAS UNABLE TO BE ESTABLISHED. SEVERAL ATTEMPTS OF TROUBLESHOOTING HAD BEEN DONE; THREE DIFFERENT PHYSICIAN PROGRAMMERS HAD BEEN USED, SEVERAL LOCATIONS WITHIN THE CLINIC WERE TRIED, DIFFERENT POSITIONS INCLUDING ON THE EXAM TABLE AND IN THE WHEELCHAIR WERE TRIED, THE LIGHTS WERE TURNED OFF AND ANY KNOWN SOURCES OF ELECTROMAGNETIC INTERFERENCE WERE ELIMINATED HOWEVER THE REPORTER WAS STILL UNABLE TO GET TELEMETRY ON THE PATIENT¿S PUMP. AN INVALID TELEMETRY MESSAGE REPORTEDLY CAME UP IMMEDIATELY. THERE WERE NO PATIENT SYMPTOMS AT THE TIME OF THE REPORT NOR WERE ANY ALARMS WERE HEARD. THE PUMP REPORTEDLY SEEMED VERY STEADY, ¿TACKED DOWN¿ AND WAS VERY PALPABLE. TELEMETRY HAD BEEN PERFORMED PREVIOUSLY SINCE IMPLANT. IT WAS NOTED THAT THE PATIENT USED A THERAPY CALLED PULSED MAGNETIC THERAPY ON VARIOUS LOCATIONS ON THEIR BODY INCLUDING THEIR BACK. THIS WAS USED BY THE PATIENT¿S CHIROPRACTOR HOWEVER IT WAS NOT USED OVER THE PUMP. IT WAS REPORTED LITTLE WAS KNOWN ABOUT THE THERAPY. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL. IT WAS LATER REPORTED THE PATIENT EXPERIENCE NO SYMPTOMS EXCEPT POOR TONE CONTROL. THE ROOT CAUSE OF THE EVENT WAS UNKNOWN AND TELEMETRY WAS NOT COMPLETED BEFORE THE PATIENT WAS SENT HOME. IT WAS REPORTED THE PATIENT WAS DOING FINE EXCEPT FOR THE POOR TONE CONTROL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PUMP WAS FILLED WITH SALINE AND THE VOLUME WAS THEN CHECKED AT A LATER DATE WHICH CONFIRMED NO FLUID WAS BEING DISPENSED. IT WAS NOTED THAT WOULD ¿SIMPLIFY DOSING WHEN THE PUMP WAS REPLACED¿. NO FURTHER TROUBLESHOOTING OR INTERVENTIONS WERE GOING TO BE DONE BEYOND WHAT HAD BEEN PREVIOUSLY REPORTED. THE PATIENT¿S FAMILY AND HEALTH CARE PROVIDER CHOSE TO HAVE THE PUMP REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212410 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention