BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1943668 · Received December 21, 2010

    Report

    Report Number
    3007566237-2010-10651
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 10, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 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

    IT WAS REPORTED THAT THE PT HEARD AN ALARM SOUND AND NOTED THAT THE THERAPY WAS NOT EFFECTIVE ANY MORE. THE PUMP CONTAINED MORPHINE 10 MG/DAY. IT WAS NOTED THAT A ROTOR STALL HAD OCCURRED. "IT WAS VERIFIED RADIOLOGICALLY THAT THE CATHETER WAS WELL POSITIONED WITH NO GRANULOMAS OR KINKINGS. SINCE THE ESTIMATED TIME BEFORE PUMP ERI (ESTIMATED REPLACEMENT INDICATOR) WAS ONLY 4 MONTHS, IT WAS DECIDED NOT TO DO ANY DIAGNOSTIC TESTS AND TO SUBSTITUTE THE PUMP." THE PUMP WAS SUBSEQUENTLY REPLACED ON (B)(6) 2010; "THERAPY BECAME EFFECTIVE AGAIN" AND "PT IS WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention