BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATTRIX

    MDR report key: 3071554 · Received April 22, 2013

    Report

    Report Number
    3007566237-2013-01387
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    April 4, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3210, SERIAL# (B)(4), IMPLANTED: (B)(6) 1997. PRODUCT TYPE: TRANSMITTER: PRODUCT ID 3888-28, LOT# *UNKN-LD, IMPLANTED: (B)(6) 1997. PRODUCT TYPE: LEAD: PRODUCT ID 3888-28, LOT# *UNKN-LD, IMPLANTED: (B)(6) 1997. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DID NOT WANT TO USE THE EXTERNAL POWER SOURCE ANY LONGER AND HAD THE DEVICE REMOVED. IT WAS NOTED THAT STIMULATION WAS EFFECTIVE AND WAS WORKING AS DESIGNED FOR THE PATIENT'S PAIN. THE REPORTER STATED IT WAS INCORRECT TO INDICATE THAT STIMULATION WAS NOT WORKING FOR THE PATIENT. IT WAS FURTHER NOTED THE LEADS WERE LEFT IMPLANTED AND A NEW DEVICE MAY BE IMPLANTED IN THE FUTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE WAS IMPLANTED IN (B)(6) 1997 AND THE PATIENT HAD GAINED SO MUCH WEIGHT THAT THE DEVICE WAS PUTTING PRESSURE AGAINST HIS INTESTINES, GIVING HIM GAS AND PAIN. THE REPORTER STATED THAT THE PATIENT WAS "IN SO MUCH PAIN FOR MONTHS AND MONTHS." IT WAS REPORTED THAT THE PATIENT HAD THROAT CANCER A LITTLE OVER A YEAR AGO AND EVER SINCE THEN HE'D BEEN HAVING THIS PROBLEM AND HE WANTED THE DEVICE OUT BECAUSE HE KNEW THAT'S WHAT WAS CAUSING THE PROBLEM. THE REPORTER STATED THAT THE PATIENT'S DOCTOR TRIED EVERYTHING FOR THE PATIENT AND HIS PAIN. IT WAS REPORTED THAT THE PATIENT LIKED THE DEVICE BUT COULDN'T TAKE THE PAIN. THE REPORTER STATED THAT THE PATIENT HAD BEEN IN THE EMERGENCY ROOM A COUPLE OF TIMES AND THEY SENT HIM HOME. TWO WEEKS LATER, IT WAS REPORTED THAT STIMULATION WAS NOT WORKING FOR THE PATIENT AT THE MOMENT. THE REPORTER STATED THAT IT WAS UNKNOWN WHY STIMULATION WASN'T WORKING. TWO WEEKS LATER, IT WAS REPORTED THAT THE PATIENT HAD THE DEVICE REMOVED. IT WAS NOTED THAT THE DEVICE WAS HURTING THE PATIENT'S SIDE. ELEVEN DAYS LATER, IT WAS REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH THE DEVICE OR THERAPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR WAS PUTTING PRESSURE AGAINST HIS INTESTINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172207 MATTRIX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 3272-51

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention