BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCRHOMED II

    MDR report key: 1220430 · Received November 4, 2008

    Report

    Report Number
    3004209178-2008-07180
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 31, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PUMP ERODED A FOURTH TIME. THE PATIENT'S PUMP WAS RELOCATED AND PLACED UNDER THE RECTAL SHEATH. THE PATIENT WAS HEALING WELL THREE WEEKS AFTER THE SURGERY. THE DRUG CONTAINED IN THE PATIENT'S PUMP WAS LIORESAL. REFERENCE MFR REPORT #3004209178200807171, 3004209178200807173, 3004209178200807178.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCRHOMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 8840| CATHETER: MODEL 8709