BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 1674098 · Received April 22, 2010

    Report

    Report Number
    3007566237-2010-03257
    Event Type
    Malfunction
    Date Received
    April 22, 2010
    Report Date
    March 26, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIRS TIME THE PT HAD THE IMPLANT, SHE ONLY FELT STIMULATION IN THE WRONG LOCATION. THE PT'S LEADS MOVED WITHIN 24 HOURS. NO PT TREATMENT OR OUTCOME WAS REPORTED. THE PT WAS LOOKING FOR A NEW PHYSICIAN TO MANAGE HER STIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SPINAL CORD STIMULATOR LGW MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PROGRAMMER: MODEL UNK, LOT # UNK| EXPLANTED:| IMPLANTED:| LEAD: MODEL UNK, LOT # UNK