BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 3181892 · Received June 21, 2013

    Report

    Report Number
    3007566237-2013-02051
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 28, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATED CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER. PRODUCT ID: 8840, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. PRODUCT ID: 8840, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. PRODUCT ID: 8840, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE HEALTH CARE PROVIDER (HCP) HAD A HARD TIME INTERROGATING THE PUMP, BUT THEN CHANGED THE PROGRAMMER AND WAS ABLE TO INTERROGATE IT. THE PUMP WAS SAID TO HAVE A LOW BATTERY AND WOULD BE REPLACED ¿IN A FEW MONTHS.¿ THE PATIENT FELT ¿TIRED¿ FOR THE ¿LAST DAY¿ PRIOR TO REPORT DATE, BUT THE HCP STATED THE PATIENT WAS NOT GOING THROUGH WITHDRAWAL. THE PUMP WAS INFUSING MORPHINE AT 1.8MG/DAY.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE INTERROGATION DIFFICULTY TOOK PLACE DURING THE INITIAL STAGES OF A REFILL PROCEDURE. THE PRINTED DATA INDICATED THE PUMP HAD STOPPED. THE CAUSE OF THE EVENT WAS DUE TO ¿MOTOR STALL.¿ IT WAS NOT CLEAR WHAT CAUSED THE STALL, UNKNOWN IF RELATED TO PROGRAMMING, BUT REPORTEDLY THE STALL DID RECOVER. THE REFILL PROCEDURE HAD NO FURTHER COMPLICATIONS. THE TELEMETRY WAS SUCCESSFULLY ACCOMPLISHED AND THE PUMP WAS RE-INTERROGATED AND UPDATED. THE PUMP WAS RE-INTERROGATED AGAIN SEVERAL MINUTES LATER TO CONFIRM THE PUMP HAD BEEN TURNED BACK ON AND READ AS SIMPLE CONTINUOUS. THERE WAS NO INJURY TO THE PATIENT AND THE PATIENT WAS DOING WELL THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282015 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 862718

    Patients

    Seq Age Sex Outcome Treatment
    1