BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATTRIX

    MDR report key: 1844581 · Received September 23, 2010

    Report

    Report Number
    3007566237-2010-07237
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    June 1, 2010
    Report Date
    August 23, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    GZF
    PMA / PMN Number
    K934065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A RETURN OF PAIN AFTER HER DEVICE STOPPED WORKING. THERE WAS NO RESPONSE FROM THE DEVICE; THE BATTERY WAS DEPLETED. NOT NORMAL DEPLETION. HER DEVICE WAS EXPLANTED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATTRIX GZF/GZB GZF MEDTRONIC NEUROMODULATION 3272 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention IMPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL ANCHOR, LOT# UNK| LEAD: MODEL 3487A, LOT# J0406375V| EXPLANTED:| LEAD: MODEL 3487A, LOT# J0406375V| IMPLANTED:| IMPLANTED:| STIM ACCESSORY: MODEL ANCHOR, LOT# UNK| EXPLANTED:| IMPLANTED:| TRANSMITTER: MODEL 3210, LOT # NBU008179P| EXPLANTED: