BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATTRIX

    MDR report key: 2872895 · Received December 13, 2012

    Report

    Report Number
    3007566237-2012-03011
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Report Date
    November 20, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3487A, LOT# L36985, IMPLANTED: (B)(6) 1995, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A, LOT# L36985, IMPLANTED: (B)(6) 1995, PRODUCT TYPE: LEAD. PRODUCT ID: 3272, SERIAL# (B)(4), IMPLANTED: (B)(6) 1995, PRODUCT TYPE: RECEIVER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A LACK OF THERAPEUTIC EFFECT. IT WAS STATED THAT THE PATIENT STIMULATOR "DIDN'T WORK" AND THAT IT WAS "VERY ERRATIC". IT WAS NOTED THAT THE PATIENT HAD NOT USED THE DEVICE FOR A YEAR OR MORE BECAUSE HE HAD ANOTHER DEVICE THAT HAD BEEN WORKING WELL. THE PATIENT STATED THAT WHEN HE GETS THE OTHER DEVICE REPLACED THAT MAYBE HE WOULD HAVE THE STIMULATOR EXPLANTED AND TRY A DIFFERENT MODEL. IT WAS NOTED THAT APPROXIMATELY TWO YEARS AGO THE DOCTOR STATED THAT THE PATIENT MAY HAVE HAD A LEAD ISSUE, BUT NOTHING WAS DONE ABOUT IT BECAUSE THE PATIENT'S OTHER DEVICE WAS WORKING. FURTHER INFORMATION HAS BEEN REQUESTED, BUT NONE WAS AVAILABLE AT THE TIME OF THIS REPORT.

    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