BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 2030450 · Received March 9, 2011

    Report

    Report Number
    3007566237-2011-01791
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 28, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT HAD A BROKEN SPINAL CATHETER. A REPLACEMENT WAS PLANNED. 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 EXPLANTED:| CATHETER: MODEL CATHETER, LOT# UNK| IMPLANTED: