BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1910648 · Received November 19, 2010

    Report

    Report Number
    3007566237-2010-09790
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    August 4, 2010
    Report Date
    November 15, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED PAIN OVER THE PUMP SITE. THE PT HAD A REVISION ON (B)(6) 2010 DUE TO PUMP EROSION THROUGH THE SKIN. THE PUMP WAS THEN EXPLANTED ON (B)(6) 2010 DUE TO INFECTION. THE MEDICATION IN THE PUMP WAS LIORESAL, CONCENTRATION 2000 MCG/ML, DOSAGE WAS 255 MCG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731SC, LOT# N202564006