BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2030401 · Received March 9, 2011

    Report

    Report Number
    3007566237-2011-01780
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 21, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT X-RAY INDICATED THAT THE CATHETER HAD MIGRATED AND WAS COILED IN THE BACK POCKET AROUND L2-3. A REPLACEMENT PROCEDURE WAS PLANNED. NO WITHDRAWAL SYMPTOMS WERE OBSERVED. IT WAS NOTED THAT THE PT WAS ON A LOW DOSAGE OF GABALON (25UG/DAY).

    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 77 YR EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8711, LOT# N213741017