BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1924835 · Received December 7, 2010

    Report

    Report Number
    3007566237-2010-10293
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 30, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A RETURN OF SYMPTOMS THAT INCLUDED NAUSEA AND INCREASED BASELINE PAIN. THE PROGRAMMING ON THE PUMP WAS CORRECT. A CATHETER DYE STUDY WAS PERFORMED AND THEY WERE UNABLE TO ASPIRATE FROM THE CAP (CATHETER ACCESS PORT) BUT THE HCP DECIDED TO "PUSH DYE IN DESPITE THAT." THE HCP WAS ALSO AWARE THAT PT WOULD RECEIVE A BOLUS OF MEDICATION AS A RESULT OF THAT ACTION. A ROLLER STUDY WAS PERFORMED WITH NO PROBLEMS. THE PT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYS WERE DILAUDID AND MARCAINE. 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 69 YR Hospitalization IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8703W, LOT# L36576