BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 2160909 · Received June 16, 2011

    Report

    Report Number
    3007566237-2011-04493
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 19, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT'S LEAD HAD MOVED CLOSER TO THE SKIN SURFACE BUT HAD NOT PUNCTURED THE SKIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| LEAD: MODEL 3887, LOT# UNK| IMPLANTED: