BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3222870 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11668
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 19, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAD MIGRATION. IT WAS STATED THAT THE PATIENT HAD MULTIPLE FALLS. THE PATIENT HAD LESS THAN 50% THERAPY RELIEF. AN X-RAY WAS TAKEN AND THE HEALTHCARE PROVIDER (HCP) COULD SEE THE LEAD MIGRATION. IT WAS STATED THAT THE MANUFACTURER REPRESENTATIVE WAS GOING TO FOLLOW-UP SOON. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LEADS MIGRATED AND THEY WERE STILL INTACT. THE MANUFACTURER REPRESENTATIVE WAS ABLE TO REPROGRAM THE PATIENT. THE PATIENT WAS REPORTEDLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321380 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