BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2770806 · Received October 3, 2012

    Report

    Report Number
    3004209178-2012-08842
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    September 5, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 399930, LOT# V002323, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID UNKN-LD, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COULD NOT INTERROGATE THE INS. AN OVERDISCHARGE WAS SUSPECTED. THE PATIENT STATED HE SAW A CODE ON THE PROGRAMMER AND WAS TOLD THAT THE ERROR CODE MEANT THE INS HAD REACHED END-OF-LIFE AND HE WOULD NEED A NEW INS. IT WAS REPORTED THAT THE PATIENT SAW THE ERROR CODE ABOUT THREE MONTHS AGO, BUT THERE WERE NO PRIOR OVERDISCHARGE EVENTS REPORTED. IT WAS NOTED THAT THE PATIENT HAD EXPERIENCED A POWER-ON-RESET IN (B)(6) 2011. THE INS WAS SCHEDULED TO BE REPLACED TODAY WITH A NEW SENSOR. 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 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1