BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 1971015 · Received January 6, 2011

    Report

    Report Number
    3007566237-2011-00138
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 26, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A RETURN OF SPASTICITY WITH UNDERDOSE/WITHDRAWAL SYMPTOMS. THESE SYMPTOMS WERE SIMILAR TO THE ONES THAT THE PT HAD EXPERIENCED BEFORE IMPLANTATION. THE PHYSICIAN WAS UNABLE TO ASPIRATE ANY FLUID THROUGH THE PT'S CATHETER ACCESS PORT (CAP). AN X-RAY AND A ROTOR TEST WERE DONE AND DID NOT REVEAL ANY KINKS, BREAKS OR DISCONNECTIONS WITH THE SYSTEM. THE CONTRAST X-RAY COULD NOT BE PERFORMED BECAUSE THE CONTRAST MEDIUM COULD NOT BE INJECTED INTO THE CAP. THE PT WAS SCHEDULED FOR A CATHETER REPLACEMENT. THE FINAL PT OUTCOME WAS UNK. ADD'L INFO HAS BEEN REQUESTED, 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 LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# 0203915384