BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1972395 · Received January 20, 2011

    Report

    Report Number
    3007566237-2011-00502
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    November 10, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PUMP REFILL ON (B)(6) 2010 AND ONE DAY LATER SHE EXPERIENCED FAINTING EPISODES AND WAS TAKEN TO THE HOSPITAL. SHE WAS UNRESPONSIVE AND TAKEN TO THE ER WHERE SHE WAS HOSPITALIZED. SHE WAS DISCHARGED FROM THE ER AND BROUGHT INTO THE CLINIC ON (B)(6) 2010, SO THAT THE MEDICATION IN HER PUMP COULD BE ASPIRATED; THE AMOUNTS WERE CORRECT. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE MORPHINE, FENTANYL, AND BACLOFEN IN A FLEX-MODE AT A RATE OF 7.99MG/DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION 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 54 YR Hospitalization| R EXPLANTED:| CATHETER: MODEL 8709, LOT# L69144| IMPLANTED: