BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2942420 · Received February 4, 2013

    Report

    Report Number
    3004209178-2013-01272
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    January 14, 2013
    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

    CONCOMITANT PRODUCTS: PRODUCT ID 3888-45, LOT# V513913, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT# V515508, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37083-40, SERIAL# (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 37083-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM HER DOCTOR OR MANUFACTURER REPRESENTATIVE AND HER CONCERNS WERE RESOLVED. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT FELL BACKWARDS AND HIT HER BACK WHERE HER LEADS WERE IMPLANTED. THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR THE DAY AFTER THE REPORT AND WOULD LIKE A MANUFACTURER REPRESENTATIVE PRESENT TO READJUST THE DEVICE AND ASSESS PROBLEMS. IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING ADEQUATE RELIEF AND THE DEVICE 'WASN'T WORKING' NOW. 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
    45926 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