BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1844813 · Received September 23, 2010

    Report

    Report Number
    3007566237-2010-07196
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    May 14, 2010
    Report Date
    September 7, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED ITCHING FOLLOWING HER LAST REFILL. IN (B)(6) 2010, IT WAS DETERMINED THAT THE CATHETER HAD FRACTURED AND MIGRATED. THE PUMP HAD MORE VOLUME THAN EXPECTED; THE VOLUMES WERE NOT PROVIDED. THE PT WAS BEING REFERRED FOR A REVISION. THE PT WAS IN A LOT OF PAIN; SHE HAD LEFT SCIATIC PAIN DOWN THE LEFT SIDE; AND HER BALANCE WAS OFF. IT WAS NOTED THAT THE PT WAS GETTING GROWTH HORMONE INJECTIONS, BUT IT WAS SO PAINFUL SHE HAD TO STOP. THE PT ALSO HAD TERRIBLE MIGRAINES. THE MEDICATION BEING DELIVERED VIA THE PUMP WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP 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 53 YR Female Required Intervention CATHETER: MODEL 8709, LOT# N084798013.| CATHETER: MODEL 8709, LOT# N084798015.| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# N084798015| EXPLANTED:| CATHETER: MODEL 8709, LOT# N084798013