BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1961104 · Received January 12, 2011

    Report

    Report Number
    3007566237-2011-00312
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 7, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PHARMACY ERROR WAS REPORTED. THE LAST TIME THE PT WAS FILLED THERE WAS AN ERROR IN THE CONCENTRATION AND HE WAS FILLED WITH 25 MCG/ML OF FENTANYL AT 9.9 MCG/DAY. THE PT EXPERIENCED UNSPECIFIED WITHDRAWAL SYMPTOMS AND RETURNED TO THE CLINIC TO BE REFILLED WITH 25 MG/ML AT 9.0 MG/DAY. THE NEW DOSE WAS CONFIRMED AND INSTRUCTIONS WERE GIVEN TO THE PT'S FATHER IN CASE OF OVERDOSE SYMPTOMS THAT COULD OCCUR RELATED TO THE SIGNIFICANT DOSAGE CHANGE; 9.9 MICROGRAMS VERSUS 9.0 MILLIGRAMS. ADDITIONAL INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention IMPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8731SC, LOT# N157082006| EXPLANTED:| CATHETER: MODEL 8709, LOT# N004909804