BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2180962 · Received July 22, 2011

    Report

    Report Number
    3007566237-2011-05684
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 5, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED, THE PUMP WAS REMOVED DUE TO INFECTION. IT WAS LATER REPORTED, THE PUMP CONTAINED LIORESAL. THE INFECTION WAS SUSPECTED. THE PT UNDERWENT A PUMP REVISION SURGERY. DURING SURGERY, UPON TESTING, IT WAS DISCOVERED THAT THE PUMP SITE WAS NOT INFECTED BUT THE PUMP SUTURES HAD COME LOOSE. THE PUMP WAS REPOSITIONED. THE PUMP REMAINED IN THE POCKET AND THE PT CONTINUED WITH BACLOFEN THERAPY. THERE WERE NO ADVERSE EVENTS. IT WAS LATER REPORTED THAT THE PUMP REVISION SURGERY DATE WAS (B)(6) 2011. THE PT HAS RECOVERED WITHOUT SEQUELAE. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention CATHETER: MODEL 8709, LOT# L55028| IMPLANTED:| EXPLANTED: