BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3423267 · Received October 22, 2013

    Report

    Report Number
    3004209178-2013-19489
    Event Type
    Malfunction
    Date Received
    October 22, 2013
    Report Date
    September 23, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37752 LOT# SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 3550-39, LOT# N267543, IMPLANTED: 2011 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3550-29, LOT# N260112, IMPLANTED: 2011 (B)(6); PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL DURING THE WEEK PRIOR TO THE REPORT AND SINCE THE FALL SHE DID NOT FEEL HER IMPLANTABLE NEUROSTIMULATOR (INS) ¿KICK IN.¿ IT WAS NOTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT WITH HER PHYSICIAN ON THE DAY OF THE REPORT. IT WAS FURTHER NOTED THAT THE PATIENT SAW A HEALTH CARE PROFESSIONAL ABOUT 2 TO 3 WEEKS AGO AND ¿SHE DID NOT BREAK ANYTHING.¿ IT WAS FURTHER NOTED THAT THE PATIENT HAD NOT HAD THE DEVICE CHECKED SINCE THE FALL. IT WAS NOTED THAT THE PATIENT INCREASED THE STIMULATION TO 6.0 VOLTS AND COULD NOT FEEL ANYTHING. IT WAS CONFIRMED THAT INS WAS ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542158 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