BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATTRIX

    MDR report key: 3770489 · Received April 24, 2014

    Report

    Report Number
    3007566237-2014-01134
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    January 1, 2008
    Report Date
    April 2, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3210, SERIAL# (B)(4), IMPLANTED: 1995-(B)(6), PRODUCT TYPE TRANSMITTER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S DEVICE WENT ¿BAD¿ AND WAS REPLACED ON 2008-(B)(6) AND NOTED THE PROBLEMS WITH THE UNIT BEGAN IN 2008. IT WAS REPORTED THE LEADS BROKE. IT WAS FURTHER REPORTED THE PATIENT HAD A BURNING SENSATION BECAUSE THE ¿UNIT HAD A FLUID LEAKING OUT OF IT¿. IT WAS NOTED THE PATIENT THIS WAS THE PATIENT¿S SECOND OR THIRD TIME THEY HAD THE UNIT CHANGED. ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS LEAD FAILURE. IT WAS REPORTED THE LEAD AND IMPLANTABLE NEUROSTIMULATOR (INS) WERE BOTH REPLACED ON 2008-(B)(6). IT WAS NOTED THE SYMPTOMS RELATED WITH THE EVENT WERE A LOSS OF PARESTHESIA COVERAGE. IT WAS NOTED THE EVENT DID NOT REQUIRE HOSPITALIZATION AND THE PATIENT IS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT STILL HAS CONCERNS WITH THEIR DEVICE OR THERAPY BUT HAS NOT SOUGHT FURTHER HELP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250089 MATTRIX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 3272-51

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention