BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 1941215 · Received December 22, 2010

    Report

    Report Number
    3007566237-2010-10705
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 13, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WITH AN INTRATHECAL BACLOFEN PUMP MAY NEED A CATHETER REVISION. THE HCP SUSPECTED THAT THE CATHETER WAS MALFUNCTIONING AND PLANNED FOR A REPLACEMENT. PER THIS REPORTER: "I THINK THE PUMP ITSELF IS WORKING FINE".

    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 Required Intervention IMPLANTED:| CATHETER: MODEL CATHETER, LOT# UNK| EXPLANTED: