BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4862867 · Received June 23, 2015

    Report

    Report Number
    3004209178-2015-12052
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Report Date
    June 2, 2015
    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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED:(B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED:(B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR YEARS PRIOR TO THE REPORT WHEN NEW BATTERIES IN THE CELL PHONE CAME OUT THE PATIENT HAD AN LG PHONE IN HER RIGHT POCKET AND FELL ASLEEP. WHEN SHE WOKE UP SHE FOUND THE CELL PHONE HAD BURNED THE INSIDE OF HER SKIN. SHE THEN REALIZED SHE HAD TO KEEP HER PHONE AWAY FROM THE INS SO IT WOULDN¿T BURN HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404493 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