BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1913537 · Received November 12, 2010

    Report

    Report Number
    6000030-2010-09404
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 28, 2010
    Manufacturer
    RICK CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXPECTED RESIDUAL VOLUME WAS 2.7 ML AND THE ACTUAL RESIDUAL VOLUME WAS 15 ML. THE PT EXPERIENCED INCREASED BASELINE PAIN DURING THE NORMAL REFILL CYCLE. THIS HAD OCCURRED MULTIPLE TIMES. PT REPEATEDLY COMPLAINED OF A LACK OF THERAPEUTIC BENEFIT FROM MEDICATIONS AND THAT PT IS ON ORAL MEDICATION AS WELL AS INTRATHECAL (IT) DRUG DELIVERY. THERE WERE NO ACTIVE ALARMS WHEN PT WAS IN THE OFFICE ON (B)(6) 2010. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICK CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT # J53426R33| EXPLANTED:| CATHETER: MODEL 8709, LOT # J12137R30