BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1960940 · Received January 11, 2011

    Report

    Report Number
    3007566237-2011-00257
    Event Type
    Injury
    Date Received
    January 11, 2011
    Report Date
    January 4, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PUMP "RIPPED LOOSE" ON 2 OCCASIONS. THE PT WAS 5 FT 5 INCHES TALL. THE FIRST EPISODE THE PUMP "RIPPED LOOSE" WAS 3 DAYS POST IMPLANT SURGERY. THE PUMP WAS POSITIONED UNDER THE RIBCAGE AND RUBBED AGAINST THE RIBCAGE. THE PT'S STOMACH, SIDE AND BACK WERE DISTENDED. CSF (CEREBROSPINAL FLUID) WAS "COMING OUT OF BACK." THE FIRST EPISODE WAS RESOLVED FOLLOWING A REVISION SURGERY. THE PT WAS AWAITING A SECOND REVISION SINCE THE PUMP "RIPPED LOOSE AGAIN." PER THE REPORTER, THE PT'S QUALITY OF LIFE WAS GREATLY IMPROVED DUE TO THE PUMP. HAVING THE PUMP WAS MORE IMPORTANT THAN THE COMPLICATIONS.

    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 Required Intervention