BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3213436 · Received July 9, 2013

    Report

    Report Number
    3004209178-2013-11495
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011: PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4): PRODUCT TYPE RECHARGER; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011: PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4): PRODUCT TYPE PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN MOVING IN HER HIP SINCE ABOUT TWO WEEKS PRIOR TO REPORT. IT WAS LATER REPORTED THE PATIENT SAW HER HEALTHCARE PROFESSIONAL ON (B)(6) 2013. THE REPORTER STATED THE PATIENT HAD NO ISSUES AND EVERYTHING WAS GOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314478 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 00072 YR