BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 2031431 · Received February 25, 2011

    Report

    Report Number
    3007566237-2011-02136
    Event Type
    Death
    Date Received
    February 25, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 2, 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 REPORTED THAT THE PT HAD HER ITB (INTRATHECAL BACLOFEN) PUMP EXPLANTED BY A GENERAL SURGEON. THE PHYSICIANS MANAGING THE PUMP WERE NOT CONSULTED OR NOTIFIED AT THE TIME THE PUMP WAS EXPLANTED. THE PT WAS IN A NURSING HOME AND THE PHYSICIAN AT THE NURSING HOME ASKED THE SURGEON TO EXPLANT THE PUMP "DUE TO ISSUES WITH GETTING HER TO HER REFILL APPOINTMENTS." THE DATE OF THE PUMP EXPLANT WAS NOT REPORTED. THE LAST PUMP REFILL WAS ON (B)(6) 2011. THE PT SUBSEQUENTLY EXPIRED. IT WAS BELIEVED THAT THE PT MAY HAVE DIED BECAUSE OF COMPLICATIONS FROM THE EXPLANT "OR NOT GETTING THE THERAPY." A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    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 66 YR Death IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8703W, LOT# L44104