BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATTRIX

    MDR report key: 2822572 · Received November 7, 2012

    Report

    Report Number
    3007566237-2012-02640
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    October 10, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3986ILC, LOT# N24890, PRODUCT TYPE LEAD; PRODUCT ID 3272-66, SERIAL# (B)(4), PRODUCT TYPE RECEIVER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION WITH THE FIRST IMPLANTABLE NEUROSTIMULATOR (INS) AND HAD IT REPLACED. NO DEVICE INFORMATION WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATTRIX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 3210

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention