BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1951993 · Received January 4, 2011

    Report

    Report Number
    3007566237-2011-00028
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 22, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE HCP (HEALTHCARE PROVIDER) PERFORMED THE PUMP'S FIRST REFILL PROCEDURE ON (B)(6) 2010. THE REFILL WAS "GOING WELL" UNTIL THE PUMP WAS FILLED WITH 32 ML OF MEDICATION; AT THAT POINT IT STOPPED. THE HCP THEN ASPIRATED ALL 32 ML OF DRUG FROM THE RESERVOIR, BUT ALSO ASPIRATED AIR. THE HCP THEN ASPIRATED "A SYRINGE OR TWO FULL OF AIR". THE HCP RE-ATTEMPTED TO FILL THE PUMP WITH DRUG; WAS AGAIN ONLY ABLE TO REFILL 32 ML. THERE WAS NO ISSUE WITH THE REFILL KIT. THE PUMP WAS NOT EXPOSED TO HYPERBARICS. IT WAS UNK BY THE REPORTER IF THE PUMP WAS ORIGINALLY FILLED WITH 40 ML OF DRUG. IT WAS ALSO UNK BY REPORTER IF THERE WAS A PT THERAPY OR MEDICAL PROBLEM. THE PUMP CONTAINED MORPHINE. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR IMPLANTED:| EXPLANTED:| CATHETER: MODEL CATHETER, LOT# UNK