BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2183685 · Received July 8, 2011

    Report

    Report Number
    3007566237-2011-05229
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    May 10, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BRIDGE BOLUS WAS INCORRECTLY PERFORMED. THE OLD CONCENTRATION WAS 15 MCG AND NEW CONCENTRATION WAS 30 MCG. THE OLD DRUG DESIRED DOSE: 8.538 MCG/DAY, AMOUNT OF BOLUS: 5.895 MCG. DURATION OF BOLUS: 16 HRS 34 MINUTES. THE PUMP WAS REPROGRAMMED WITH THE NEW AND CORRECT SETTINGS. NO PT ADVERSE EVENTS WERE REPORTED AND THE PT OUTCOME WAS REPORTED AS "DOING FINE". THE DRUGS INFUSED VIA THE PUMP INCLUDED SUFENTANIL (OLD 15 MCG/ML CONC. 8.538 AND NEW 30 MCG/ML, CONC. 9.829) AND BUPIVACAINE NEW 2.5 MG/ML.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR EXPLANTED:| CATHETER: MODEL 8709, LOT# N098666010| EXPLANTED:| PROGRAMMER: MODEL 8840, LOT# UNK| IMPLANTED:| IMPLANTED: