BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4650398 · Received April 1, 2015

    Report

    Report Number
    3007566237-2015-00847
    Event Type
    Malfunction
    Date Received
    April 1, 2015
    Report Date
    March 11, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8578, LOT# N150639, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709, LOT# J11193R06, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: CATHETER. PRODUCT ID: 8840, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS "VERY, VERY SPASTIC" AND HAD A CHANGE IN THERAPY EFFECT BEGINNING LAST WEEK. THE PATIENT WAS SEEN ON THE DATE OF THIS REPORT FOR A DOSAGE INCREASE. WHEN THE HEALTHCARE PROFESSIONAL (HCP) INTERROGATED THE PUMP, THE CLINICIAN PROGRAMMER SHOWED THE FOLLOWING PUMP MESSAGE; "THERAPY STOPPED INACTIVE USE MINIMUM RATE INFUSION MODE". THE HCP THOUGHT "MAYBE SINCE ELECTIVE REPLACEMENT INDICATOR (ERI) [WAS] IN 2 MONTHS, THE PUMP STARTING TO FAIL". IT WAS NOTED THERE WERE NO STALL IN THE PUMP LOGS AND NOTHING ELSE IN THE LOGS TO INDICATED A PROBLEM. THE HCP CONFIRMED IT WAS POSSIBLE THEY HIT THE RED THERAPY STOP BUTTON ON THEIR PROGRAMMER. THE HCP WAS ABLE TO SUCCESSFULLY NAVIGATE OUT OF "THIS" SCREEN AND IT RESOLVED THE ISSUE. THE PUMP WAS UPDATED WITHOUT A PROBLEM, THE DOSAGE WAS INCREASED TO 739.4 MCG/DAY AND THE PATIENT WAS GIVEN ORAL BACLOFEN TO USE AS NEEDED. THE PATIENT'S MOTHER REPORTED THE PATIENT HAD IMPROVED AND DID NOT NEED THE ORAL BACLOFEN. THE PATIENT WOULD RETURN ON (B)(6) /2015 FOR A ROUTINE PUMP REFILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214643 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00023 YR