BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2853146 · Received November 30, 2012

    Report

    Report Number
    3004209178-2012-10993
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Report Date
    November 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS ONLY ABLE TO GET ONE OF HER LEADS TO WORK. WHEN THE PATIENT PRESSED THE SYNC BUTTON IT TURNED HER STIMULATION OFF. IT WAS NOTED THAT THE PATIENT WAS CONFIDENT SHE PRESSED THE SYNC BUTTON. THE PATIENT WAS ONLY ABLE TO ACCESS THE LEAD THAT CONTROLS HER KNEE, AND SHE COULD NOT ACCESS THE SECOND LEAD. IT WAS REPORTED THAT THE PATIENT HAD A 'PINS AND NEEDLES' SENSATION IN HER LEFT FOOT. IT WAS NOTED THAT THE PATIENT HAS TO RECHARGE HER DEVICE MORE FREQUENTLY. FURTHER INFORMATION WAS REQUESTED, BUT NONE WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1