BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2823480 · Received November 8, 2012

    Report

    Report Number
    3004209178-2012-10030
    Event Type
    Injury
    Date Received
    November 8, 2012
    Report Date
    October 11, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-75, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3777-75, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER, PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NO FEELING IN HIS LEFT ARM AND THAT IT HAD BEEN LIKE THIS FOR A LONG TIME. IT WAS UNCLEAR IF THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) CONTRIBUTED OR CAUSED THIS EVENT. IT WAS NOTED THAT THE PATIENT BROKE HIS BACK AT THE AGE OF 19 AND THAT THEY HAD ARTHRITIS IN THEIR SPINE. IT WAS ALSO REPORTED THAT THE PATIENT'S X-RAYS WERE "BLATANTLY MISREAD TO PROVIDE CARE". ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability