BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 2871602 · Received December 13, 2012

    Report

    Report Number
    3004209178-2012-11786
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Report Date
    November 19, 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 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37092, LOT # 285700002, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY; PRODUCT ID 3550-39, LOT # N279670, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL ON HIS BACK THREE TO FOUR MONTHS PRIOR TO THE REPORT AND HIS SYSTEM HAD NOT BEEN WORKING. THE PATIENT FELT A LUMP AND HAD LESS THAN 50% THERAPY RELIEF. NO FURTHER INFORMATION WAS PROVIDED.

    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