BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1636627 · Received March 19, 2010

    Report

    Report Number
    6000030-2010-02251
    Event Type
    Injury
    Date Received
    March 19, 2010
    Date of Event
    November 1, 2009
    Report Date
    February 19, 2010
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED SEIZURES WHENEVER THE PUMP DOSE WAS INCREASED. THE PT'S THERAPY WASN'T AS EFFECTIVE AS HOPED. THE PT'S MOTHER PREFERRED THE PUMP TO BE EXPLANTED RATHER THAN REPLACED FOLLOWING SURGERY FOR EROSION (REFER TO MFR'S REPORT # 6000030-2010-02252).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention CATHETER: MODEL 8709, LOT# J11766R12| PROGRAMMER: MODEL PROGRAMMER, LOT# UNK| IMPLANTED:| EXLPANTED: