BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1982671 · Received February 2, 2011

    Report

    Report Number
    3007566237-2011-00836
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    January 1, 2008
    Report Date
    January 27, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED DISCHARGE FROM THE INCISION IN HIS BACK APPROX 6 WEEKS AFTER IMPLANT. THE CATHETER WAS REMOVED; THE PUMP REMAINED IMPLANTED. THE PT WAS GIVEN ANTIBIOTICS. APPROX ONE MONTH LATER, OOZING FROM THE INCISION SITE OF THE PUMP WAS NOTED. IT WAS SUBSEQUENTLY REMOVED AND THE PT WAS PUT ON INTRAVENOUS ANTIBIOTICS. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention CATHETER: MODEL 8709SC, LOT#N140841020| IMPLANTED:| EXPLANTED: