BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2032527 · Received March 24, 2011

    Report

    Report Number
    3007566237-2011-02253
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 8, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-2276-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DEVICE HAS BEEN RETURNED TO THE MFR FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PUMP SHOWED AN EARLY ERI (ELECTIVE REPLACEMENT INDICATOR); IT SHOWED ON (B)(6) 2011. AT LAST CHECK (DATE NOT REPORTED), IT SHOWED "OTHER ERI." THE PUMP WAS REPLACED. THERE WAS REPORTED TO BE NO PT INJURY. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL.

    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 19 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8709, LOT # J12175R33| EXPLANTED: