BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4318408 · Received December 10, 2014

    Report

    Report Number
    3007566237-2014-03577
    Event Type
    Malfunction
    Date Received
    December 10, 2014
    Report Date
    November 14, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. PRODUCT ID: 8590-1, LOT# N252652, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED PATIENT SYMPTOMS INCLUDED TIREDNESS, MOOD CHANGE AND CONFUSION. THE PATIENT¿S ALARM HAD GONE OFF AND THEIR HUSBAND REPORTEDLY DIDN¿T REALIZE THE PUMP NEEDED TO BE REFILLED. OTHER MEDICATIONS INCLUDING ORALLY THE PATIENT WAS TAKING AT THE TIME OF THE EVENT INCLUDED BUT WERE NOTED LIMITED TO BACLOFEN, AVONEX, NORCO, METOPROLOL, ZOLOFT AND OXYBUTYNIN. ADDITIONAL ILLEGIBLE MEDICATIONS WERE LISTED. ADDITIONAL CLARIFYING INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. IN TERMS OF HOW THEY WERE NOW DOING, IT WAS NOTED THEY RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MISSED REFILL OCCURRED. AN ALARM WAS HEARD. TELEMETRY CONFIRMED THE LOW RESERVOIR ALARM OCCURRED ON (B)(6) 2014 AT 6AM AND THE EMPTY RESERVOIR ALARM OCCURRED ON (B)(6) 2014 AT 10PM. THE PATIENT WAS STARTED ON ORAL BACLOFEN ON THE DAY PRIOR TO THIS REPORT. THE PATIENT WAS ¿GRUMPIER¿, BUT THERE WERE NO THERAPY PROBLEMS. ON THE DATE OF THIS REPORT, THE PUMP WAS REFILLED AS NORMAL AND THE DOSE WAS DECREASED TO 40MCG. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN, LIKELY LIORESAL. THE FINAL PATIENT OUTCOME WAS NOT REPORTED. FURTHER FOLLOW-UP WAS CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799385 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR