BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATTRIX

    MDR report key: 2250638 · Received September 13, 2011

    Report

    Report Number
    3007566237-2011-07814
    Event Type
    Injury
    Date Received
    September 13, 2011
    Report Date
    July 28, 2025
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    GZF
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HIT WHILE RIDING ON HIS BIKE AND WAS THROWN 20 FEET. THE PATIENT GOT X-RAYS DONE AT THE HOSPITAL ON (B)(6) 2011 IN AZ. HE WAS OUT IN TWO DAYS AND WAS NOT TOLD THE RESULTS. THE PATIENT WAS IN SC AND HAD THREE SPOTS BROKEN IN HIS SHOULDER BLADE AND RIBS AND THE HCP WANTED TO DO AN MRI. IT WAS REPORTED THAT THE PATIENT HAD CRUNCHING AND SNAPPING IN HIS LOWER BACK NOW. IT WAS ALSO REPORTED THAT THE PATIENT LOST A PATIENT DEVICE (PROBABLY REFERRING TO THE TRANSMITTER) THREE YEARS AGO. THE PATIENT WAS UNAWARE OF THE STATUS OF HIS DEVICE (PROBABLY REFERRING TO THE RECEIVER). ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 NA Male Hospitalization EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED: | LEAD: MODEL 3487A, LOT# L51033.| LEAD: MODEL 3487A, LOT# L60688.| TRANSMITTER: MODEL 3210, LOT# NBU006718P.| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3487A, LOT# L60688| EXPLANTED:| EXPLANTED:| TRANSMITTER: MODEL 3210, LOT# NBU006718P| LEAD: MODEL 3487A, LOT# L51033| IMPLANTED: